Smart connection interface

ABSTRACT

A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.15/655,815, filed Jul. 20, 2017, which is a Continuation of U.S. patentapplication Ser. No. 15/344,442, filed Nov. 4, 2016, U.S. Pat. No.9,744,290, granted Aug. 29, 2017, which is a Continuation of U.S. patentapplication Ser. No. 14/803,944, filed Jul. 20, 2015, U.S. Pat. No.9,517,299, granted Dec. 13, 2016, which is a Divisional of U.S. patentapplication Ser. No. 14/801,503, filed Jul. 16, 2015, U.S. Pat. No.9,452,255, granted Sep. 27, 2016, incorporated herein by reference intheir entirety and claim priority of U.S. Provisional Patent ApplicationNos. 62/027,019, filed Jul. 21, 2014; 62/087,445, filed Dec. 4, 2014;62/150,064, filed Apr. 20, 2015; 62/159,504, filed May 11, 2015, whichare incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present disclosure relates to connection interfaces for syringes andreservoirs and, in particular embodiments, to connection interfaces forinterfacing a syringe or reservoir to an infusion pump, infusion settubing, or both. Further embodiments relate to infusion pump systems andinfusion set systems that include such connection interfaces, and tomethods that employ the same.

2. Description of the Related Art

Infusion pump devices and systems are used in medical contexts, todeliver or dispense infusion media to patients, where such infusionmedia may be, for example, a prescribed medication such as insulin, acancer therapy drug, an HIV therapy drug or other media for treating amedical or biological condition. In one form, such infusion pump deviceshave a relatively compact pump housing adapted to receive a syringe orreservoir that contains a prescribed medication for administration to apatient.

Infusion pump devices typically include a small drive motor connectedthrough a drive linkage to a piston in the syringe or reservoir. Thedrive motor operates to selectively move the piston within the syringeor reservoir, to drive fluidic media from the reservoir and to the user.Programmable controls are normally provided for operating the drivemotor continuously or at periodic intervals to obtain a controlleddelivery of the medication over a period of time. Such infusion pumpsare utilized to administer insulin and other medications, with exemplarypump constructions being shown and described in U.S. Pat. Nos.4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122, each of whichis incorporated by reference herein, in its entirety.

Infusion sets are tubing and connection apparatus that provide a fluidflow path for infusion media to flow from the reservoir or syringe inthe pump to the user. Connectors for attaching the infusion set tubingto the reservoirs can take various forms. Some examples of suchconnectors are described in U.S. Pat. No. 6,585,695, which isincorporated by reference herein, in its entirety.

Nevertheless, it remains desirable to develop improved designs ofconnection methods to facilitate infusion procedures and to providesuitable interface connections that provide additional features for easeof use and manufacture, and other advantages.

SUMMARY OF THE PREFERRED EMBODIMENTS

Connection interfaces for syringes and reservoirs are configured forinterfacing a syringe or reservoir to an infusion pump, infusion settubing, or both. Infusion pump systems include infusion pump devices,infusion sets and connection interfaces that connect the infusion pumpdevices with the infusion sets. In particular embodiments, theconnection interfaces include a cap configured to be secured to areservoir to form a reservoir/cap unit (or base/reservoir/cap unit) thatis configured to be installed within a reservoir receptacle of aninfusion pump device. In particular embodiments, the cap includes afirst releasable coupler and a second releasable coupler, where thefirst releasable coupler releasably attaches the cap to the reservoir(or to a base fixed to the reservoir) to form the reservoir/cap unit (orbase/reservoir/cap unit), while the second releasable coupler releasablyattaches the cap to the infusion pump device.

In particular embodiments, at least one detectable feature is arrangedon the cap or the reservoir for detection by at least one sensor elementwhen the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device. The sensor element maybe any one or more of a magnetic detection sensor, an inductive sensor,an RF sensor, a mechanical detection sensor, an optical sensor or anelectronic contact sensor. Similarly, the detectable feature may be anyone or more of a magnetically detectable feature, an inductivelydetectable feature, an RF detectable feature, a mechanically detectablefeature, on optically detectable feature and an electronic contactdetectable feature.

Also, particular embodiments relate to particular second releasablecouplers configured to releasably attach the cap to the infusion pumpdevice that, in further embodiments, are employed with any one or moreof the embodiments that employ detectable features. Yet otherembodiments relate to reservoir filling systems and processes includingor employing transfer guards for filling reservoirs that, in furtherembodiments, are reservoirs to which a cap secures to form areservoir/cap unit (or base/reservoir/cap unit).

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device to receive a reservoircontaining infusion media and to selectively dispense the infusion mediafrom the reservoir when the reservoir is inserted and secured in aninfusion pump housing of the infusion pump device. The infusion pumpsystem according to such embodiment also includes at least one sensorelement held by the infusion pump device, and a connector interface toconnect the reservoir with the infusion pump device, where the connectorinterface includes a cap to connect to the reservoir to form areservoir/cap unit. The infusion pump system according to suchembodiment also includes at least one detectable feature arranged on thereservoir/cap unit for detection by the at least one sensor element onthe infusion pump device when the cap is aligned or coupled with theinfusion pump housing.

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device to receive a reservoircontaining infusion media and to selectively dispense the infusion mediafrom the reservoir when the reservoir is inserted and secured in aninfusion pump housing of the infusion pump device; at least one sensorelement held by the infusion pump device; a connector interface toconnect the reservoir with the infusion pump device, the connectorinterface including a cap to connect to the reservoir to form areservoir/cap unit; and at least one detectable feature arranged on thereservoir/cap unit for detection by the at least one sensor element onthe infusion pump device when the cap is aligned or coupled with theinfusion pump housing.

In particular embodiments, the at least one detectable feature is amagnet or a magnetic strip. In particular embodiments, the at least onedetectable feature is an inductively detectable member. In particularembodiments, the at least one detectable feature is a radio frequency(RF) detectable device. In particular embodiments, the at least onedetectable feature is a mechanically detectable feature. In particularembodiments, the at least one detectable feature is an opticallydetectable feature.

In particular embodiments, the connector interface further includes atwist-lock with push button release feature. In particular embodiments,the connector interface further includes a rotatable ring lock andrelease feature. In particular embodiments, the connector interfacefurther includes a pawl push-in lock with pinch release feature. Inparticular embodiments, the connector interface further includes a slotand tab connection feature. In particular embodiments, the connectorinterface further includes a spring connection feature.

In particular embodiments, the infusion pump system includes aside-loading reservoir receptacle.

In particular embodiments, the connector interface further includes avent on the cap or on the infusion pump device.

In particular embodiments, the at least one sensor element and the atleast one detectable feature are configured such that detection is byone or more of magnetic effects, inductive effects, RF or RFIDinteraction, mechanical interaction, optical effects, and electricalcontact.

Magnetic Detection

An infusion pump system according to a further embodiment of the presentinvention includes an infusion pump device having a reservoir receptaclefor receiving a reservoir containing an infusion media, and forselectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, where infusionpump device includes at least one magnetic detection sensor element. Theinfusion pump system embodiment further includes a connector interfacesystem for connecting the reservoir with the infusion pump device. Inparticular embodiments, a connector interface system includes a capconfigured to connect to the reservoir to form a reservoir/cap unit, andwhere at least one magnetic detectable feature is arranged on the cap orthe reservoir for detection by the at least one sensor element when thereservoir of the reservoir/cap unit is received in the reservoirreceptacle of the infusion pump device. In further embodiments, theconnector interface system includes the reservoir to be received withinthe reservoir receptacle of the infusion pump device, where thereservoir contains or is to contain infusion media to be selectivelydispensed from the reservoir when the reservoir is received within thereservoir receptacle. In further embodiments, the connector interfacesystem includes an infusion set coupled to the cap via a tubing forconveying infusion media dispensed from the reservoir.

A connector interface system according to an embodiment of the presentinvention includes a cap to connect to a reservoir to form areservoir/cap unit for installation into an infusion pump device. Atleast one magnetic detectable feature is arranged on the cap fordetection by at least one sensor element on the infusion pump devicewhen the reservoir of the reservoir/cap unit is received in a reservoirreceptacle of the infusion pump device, where the at least one magneticdetectable feature includes a magnet that is attached to a housing ofthe cap.

A connector interface system according to further embodiments of thepresent invention includes a reservoir to be received within a reservoirreceptacle of an infusion pump device, the reservoir to contain infusionmedia to be selectively dispensed from the reservoir when the reservoiris received within the reservoir receptacle. The connector interfacesystems according to such further embodiments also include a connectorinterface to connect the reservoir with the infusion pump device, theconnector interface including a cap to connect to the reservoir to forma reservoir/cap unit. The connector interface systems according to suchfurther embodiments also includes an infusion set coupled to the cap viaa tubing for conveying infusion media dispensed from the reservoir, andat least one magnetic detectable feature arranged on the cap fordetection by at least one sensor element on the infusion pump devicewhen the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device. The at least onemagnetic detectable feature includes a magnet that is attached to ahousing of the cap.

The use of a magnet in the cap helps with the automatic detection ofwhether the reservoir is fully secured in the pump. Once securedinfusion can start. If the reservoir subsequently works loose, infusioncan be interrupted and an alarm sounded. In a preferred embodiment aninfusion pump for a medication fluid includes a receptor for a reservoirof the medication fluid; a first replaceable reservoir positionablewithin the reservoir receptor, said reservoir having: a cap which, whenthe replaceable reservoir is within the reservoir receptor, is rotatablewith respect to the infusion pump from a first position where thereservoir is locked within the receptor, and a second position where thereservoir may be removed from the reservoir receptor; a magnet situatedon the cap; a sensor in the infusion pump configured to produce thesignal dependent on detected magnetic field; the magnet and the sensorbeing positioned so that the detected magnetic field when the cap is inthe first position differs from the magnetic field when the cap is inthe second position; circuitry connected to the sensor to determine fromthe signal whether the reservoir is in the first position (locked) orthe second position (worked loose or undone for removal). The aspect ofthe magnetic field that is sensed may be any of magnetic field strength,magnet field polarity or magnet field direction or any combinationthereof, such as magnetic field strength in a particular direction.

The magnet and sensor may be positioned to be adjacent when the cap isin the first position, and separated when the cap is in the secondposition; and said circuitry is configured such that the cap isindicated as being in the first position when the magnetic fieldstrength at the sensor exceeds a first threshold value.

Various alternatives are possible including one in which the sensorincludes two magnetic detectors and the circuitry detects the firstposition when the field strength detected by the first detector is equalto the field strength detected by the second detector indicating thatthe magnet is equidistant from the first and second magnetic detectors.This arrangement can even be combined with the first such that a firstdetector detects a first magnet by its field strength maximum toindicate its proximity and the other two detect a position of equalfield strength. In such an arrangement the cap has two magnets disposedwith an angular separation with respect to the axis of the cap and theinfusion pump has three sensors, the first of which is positionedadjacent the magnet when the cap is in the first position and separatedwhen the cap is in the second position and the second and third sensorsbeing positioned to be angularly equidistant from the second magnet whenthe cap is in the first position, and the circuitry is arranged todetect the first position when the magnetic field strength exceeds afirst threshold value as detected by the first sensor and when themagnetic field strength as detected by the second and third sensor areequal. In a further development the cap has three magnets spaced at anangle θ and the infusion pump has four sensors, a first being positionedadjacent a first sensor when the cap is in the first position; thesensors being spaced at an angle θ, the magnets being positioned withrespect to the first magnet at angles of a half (2n+1) θ, where nrepresents consecutive integers 1, 2, 3, etc., and said magnetsalternate in polarity for successive values of n; said circuitry beingarranged to detect the first position when the magnetic field strengthdetected by the first sensor is a maximum, and the sum of the magneticfield strength for the other sensors equals zero.

In these arrangements the pump can be made to distinguish between onereservoir and a different reservoir, say with a different insulin, andrequiring different dosing by including a second replaceable reservoirpositionable within the reservoir receptor in place of the firstreplaceable reservoir, wherein the magnets of the first and secondreplaceable reservoirs all have respective opposite polarities, thesensor being arranged to be able to detect the opposite polarity whenthe second replaceable reservoir is in the first position, the circuitrybeing configured to indicate that the second replaceable reservoir is inthe infusion pump rather than the first replaceable reservoir.

In particular embodiments, the at least one magnetic detectable featurehas at least one detectable parameter that is associated with one ormore characteristics of the cap, the reservoir, a cannula, or a tubingconnected between the cap and the cannula. In particular embodiments,the association is provided in a table or other data arrangement.

In particular embodiments, the one or more characteristics includes oneor more of: a type or identity of a manufacturer of the reservoir or thecap; a size of the reservoir or the cap; a type or concentration ofinfusion media in the reservoir; a volume amount of infusion media inthe reservoir; a date corresponding to a manufacturing date, expirationdate, or fill date related to infusion media in the reservoir; a datecorresponding to a manufacturing date or expiration date of thereservoir or the cap; a location corresponding to a place where thereservoir or infusion media in the reservoir was made, filled, orotherwise processed; a location corresponding to a place where the capwas made, assembled, or otherwise processed; a location corresponding toa place where the reservoir, infusion media in the reservoir, or the capis authorized to be used; a lot number or code associated with a batchin which the reservoir, the cap, or infusion media was made, cleaned,filled, or otherwise processed; a serial number; a unique ID; useridentification information for authorized users; a type, length, or sizeof the cannula; or a type, length, or size of the tubing connectedbetween the cap and the cannula.

In particular embodiments, the at least one detectable parameter of themagnetic detectable feature includes one or more of: proximity of the atleast one magnetic detectable feature, polarity direction of the atleast one magnetic detectable feature, field strength of the at leastone magnetic detectable feature, location on the cap of the at least onemagnetic detectable feature, or pattern of locations on the cap of aplurality of magnetic detectable features.

In particular embodiments, the at least one magnetic detectable featurehas a first polarity direction arranged to saturate the at least onesensor element in a first saturation state when the reservoir of thereservoir/cap unit is fully received in the reservoir receptacle of theinfusion pump device, or a second polarity direction arranged tosaturate the at least one sensor element in a second saturation statewhen the reservoir of the reservoir/cap unit is fully received in thereservoir receptacle of the infusion pump device, the first saturationstate being opposite to the second saturation state.

In particular embodiments, the at least one magnetic detectable featureincludes a compass sensor detectable feature having a detectableresolution associated with one or more predefined characteristics of thecap, the reservoir, a cannula, or a tubing connected between the cap andthe cannula.

In particular embodiments, the at least one magnetic detectable featureincludes a plurality of magnets arranged at different respectivelocations on the cap.

In particular embodiments, the at least one magnetic detectable featureincludes a plurality of magnetic detectable features in locations thatallow the magnetic detectable features to magnetically interact with theat least one sensor element to provide detectable signals for detectionof axial or rotational motion or position of the cap or the reservoirrelative to the reservoir receptacle, when the reservoir/cap unit isreceived in the reservoir receptacle.

In particular embodiments, the cap includes at least one thread arrangedto engage a corresponding thread or groove in the infusion pump devicewhen the reservoir/cap unit is received in the reservoir receptacle inthe infusion pump device, wherein the at least one magnetic detectablefeature is located on the at least one thread.

In particular embodiments, the at least one magnetic detectable featureincludes a magnetic field angle associated with one or more predefinedcharacteristics of the cap, the reservoir, a cannula, or a tubingconnected between the cap and the cannula.

In particular embodiments, the at least one magnetic detectable featureincludes a magnetic field that is inclined at an angle β relative to aside of the cap. This magnetic field can be independent of a shape ofthe magnet used to produce it.

In particular embodiments, the at least one magnetic detectable featureincludes a magnetic field that is inclined at an angle β relative to aside of the cap, wherein the angle β is between 5° to 85°, 95° to 175°,185° to 265°, or 275° to 355° relative to the side of the cap.

In particular embodiments, the at least one magnetic detectable featureincludes a magnetic field that is inclined at an angle β relative to aside of the cap, wherein the angle β is between 2.5° to 87.5°, 92.5° to177.5°, 182.5° to 267.5°, or 272.5° to 357.5° relative to the side ofthe cap.

In particular embodiments, the at least one magnetic detectable featureincludes a magnetic field that is inclined at an angle β relative to aside of the cap, the angle β is between 10° to 80°, 100° to 170°, 180°to 260°, or 285° to 350° relative to the side of the cap.

In particular embodiments, the at least one magnetic detectable featureincludes a magnetic field that is inclined at an angle β relative to aside of the cap, wherein angle β is set to provide a three-dimensionalmagnetic field angle α relative to the side of the cap.

In particular embodiments, the at least one magnetic detectable featureincludes two or more magnets included in the cap, wherein each magnethas its own magnetic field set at an independently set angle β relativeto a side of the cap.

In particular embodiments, the at least one magnetic detectable featurehas at least one detectable parameter that is associated with one ormore characteristics of the cap, the reservoir, a cannula, or a tubingconnected between the cap and the cannula, wherein as the cap is rotatedinto the infusion pump device, the two or more magnets create a magneticfield sequence that uniquely identifies the one or more characteristicsof the cap, the reservoir, a cannula, or a tubing connected between thecap and the cannula.

In particular embodiments, the infusion set further includes a cannula,and the at least one magnetic detectable feature has at least onedetectable parameter that is associated with one or more characteristicsof the cannula or the tubing of the infusion set.

In particular embodiments, the characteristic of the cannula or thetubing of the infusion set includes a size or length of the cannula, ora size or length of the tubing.

An infusion pump system according to embodiments of the presentinvention includes an infusion pump device having a reservoir receptacleto receive a reservoir containing infusion media and to selectivelydispense the infusion media from the reservoir when the reservoir isreceived within the reservoir receptacle. The infusion pump systemembodiments further include at least one sensor element held by theinfusion pump device, and a connector interface to connect the reservoirwith the infusion pump device, where the connector interface includes acap to connect to the reservoir to form a reservoir/cap unit. Theinfusion pump system embodiments further include at least one magneticdetectable feature arranged on the cap for detection by the at least onesensor element on the infusion pump device when the reservoir of thereservoir/cap unit is received in the reservoir receptacle of theinfusion pump device, where the at least one magnetic detectable featureincludes a magnet that is attached to a housing of the cap.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature has at least one detectable parameter thatis associated with one or more characteristics of a cannula or a tubingof an infusion set associated with the connector interface.

In particular embodiments of the infusion pump system, thecharacteristic of the cannula or the tubing of the infusion set includesa size or length of the cannula, or a size or length of the tubing.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature has at least one detectable parameter thatis associated with one or more characteristics of the cap, thereservoir, or a tubing connected between the cap and a cannula.

In particular embodiments of the infusion pump system, the at least onedetectable parameter includes one or more of: proximity of the at leastone magnetic detectable feature, polarity direction of the at least onemagnetic detectable feature, field strength of the at least one magneticdetectable feature, location on the cap of the at least one magneticdetectable feature, or pattern of locations on the cap of a plurality ofmagnetic detectable features.

In particular embodiments of the infusion pump system, the at least onesensor is configured to be saturated in a first saturation state whenthe reservoir of the reservoir/cap unit having a magnetic detectablefeature of a first polarity direction is fully received in the reservoirreceptacle of the infusion pump device, and wherein the at least onesensor is configured to be saturated in a second saturation state whenthe reservoir of the reservoir/cap unit having a magnetic detectablefeature of a second polarity direction is fully received in thereservoir receptacle of the infusion pump device, the first saturationstate being opposite to the second saturation state, and the firstpolarity direction being opposite to the second polarity direction.

In particular embodiments of the infusion pump system, in the one ormore characteristics includes one or more of: a type or identity of amanufacturer of the reservoir or the cap; a size of the reservoir or thecap; a type or concentration of the infusion media in the reservoir; avolume amount of the infusion media in the reservoir; a datecorresponding to a manufacturing date, expiration date, or fill daterelated to the infusion media in the reservoir; a date corresponding toa manufacturing date or expiration date of the reservoir or the cap; alocation corresponding to a place where the reservoir or the infusionmedia in the reservoir was made, filled, or otherwise processed; alocation corresponding to a place where the cap was made, assembled, orotherwise processed; a location corresponding to a place where thereservoir, the infusion media in the reservoir, or the cap is authorizedto be used; a lot number or code associated with a batch in which thereservoir, the cap, or the infusion media was made, cleaned, filled, orotherwise processed; a serial number; a unique ID; user identificationinformation for authorized users; a type, length, or size of thecannula; or a type, length, or size of the tubing connected between thecap and the cannula.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a compass sensor detectable featurehaving a detectable resolution associated with one or more predefinedcharacteristics of the cap, the reservoir, a cannula, or a tubingconnected between the cap and the cannula.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a plurality of magnets arranged atdifferent respective locations on the cap.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a plurality of magnetic detectablefeatures in locations that allow the magnetic detectable features tomagnetically interact with the at least one sensor element to providedetectable signals for detection of axial or rotational motion orposition of the cap or the reservoir relative to the reservoirreceptacle, when the reservoir/cap unit is received in the reservoirreceptacle.

In particular embodiments of the infusion pump system, the at least onesensor is configured to detect a magnetic field angle of the at leastone magnetic detectable feature, the magnetic field angle beingassociated with one or more predefined characteristics of the cap, thereservoir, a cannula, or a tubing connected between the cap and thecannula.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a magnetic field that is inclinedat an angle β relative to a side of the cap and independent of a shapeof the magnet to produce an angled magnetic field at the angle β.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a magnetic field that is inclinedat an angle β relative to a side of the cap, wherein the angle β isbetween 5° to 85°, 95° to 175°, 185° to 265°, or 275° to 355° relativeto the side of the cap.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a magnetic field that is inclinedat an angle β relative to a side of the cap, wherein the angle β isbetween 2.5° to 87.5°, 92.5° to 177.5°, 182.5° to 267.5°, or 272.5° to357.5° relative to the side of the cap.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a magnetic field that is inclinedat an angle β relative to a side of the cap, the angle β is between 10°to 80°, 100° to 170°, 180° to 260°, or 285° to 350° relative to the sideof the cap.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes a magnetic field that is inclinedat an angle β relative to a side of the cap, wherein angle β is set toprovide a three-dimensional magnetic field angle α relative to the sideof the cap.

It is preferred to set the magnet in the side of the cap such that theNorth-South magnetic field direction lies in the wall of the cap, is atan angle with and intersects the plane containing the axis of the cap,i.e. skew and on the side of the cap. It is also possible however toorient the magnetic field so that it lies in the surface of ahypothetical cone coaxial with the cap i.e. tilt, with or without theskew. The sensor would then be arranged to detect the field directionand interpret it as the characteristics discussed above. In either caseit is preferable not to orient the magnetic field directly parallel ortransverse to the axis of the cap.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature includes two or more magnets included in thecap, wherein each magnet has its own magnetic field set at anindependently set angle β relative to a side of the cap.

In particular embodiments of the infusion pump system, the at least onemagnetic detectable feature has at least one detectable parameter thatis associated with one or more characteristics of the cap, thereservoir, a cannula, or a tubing connected between the cap and thecannula, wherein as the cap is rotated into the infusion pump device,the two or more magnets create a magnetic field sequence that uniquelyidentifies the one or more characteristics of the cap, the reservoir, acannula, or a tubing connected between the cap and the cannula.

A further option in these arrangements is to provide electronics coupledto the output of the sensor, which defines a first threshold of magneticfield detection indicating that the reservoir cap combination is in thevicinity of the infusion pump. This first threshold could simply betriggered by the detection of a given minimum magnetic field strength. Asecond threshold of magnetic field detection would indicate that thereservoir/cap unit is secured in place on the pump. This could either bedetermined by a maximum in magnetic field strength, either with aparticular orientation or regardless of orientation. A third criterioncould then be derived from the detected field angle when the cap is inplace, with different measured angle representing differentcharacteristics, as discussed above. These characteristics can be fed tothe pump to determine operation, or to determine that the reservoir/capcombination is unauthorized or unsuitable for use with that pump, inwhich case the pump would shut down and/or an audible or visual warningbe given.

An infusion pump system for a medication fluid according to furtherembodiments of the present invention includes a receptacle for areservoir of the medication fluid and a first replaceable reservoirpositionable within the reservoir receptacle. In such embodiments, thereservoir has a cap which, when the replaceable reservoir is within thereservoir receptacle, is rotatable with respect to the infusion pumpfrom a first position where the reservoir is locked within thereceptacle, and a second position where the reservoir may be removedfrom the reservoir receptacle. Such embodiments include a magnetsituated on the cap and a sensor in the infusion pump configured toproduce the signal dependent on detected magnetic field. The magnet andthe sensor are positioned so that the detected magnetic field when thecap is in the first position differs from the magnetic field when thecap is in the second position. Such embodiments include circuitryconnected to the sensor to determine from the signal whether thereservoir is in the first position or the second position.

In particular embodiments, the magnet and sensor are positioned to beadjacent when the cap is in the first position, and separated when thecap is in the second position, and the circuitry indicates that the capis in the first position when the magnetic field strength exceeds afirst threshold value.

In particular embodiments, the circuitry is configured to indicate thatthe reservoir is in the reservoir receptacle irrespective of whether thecap is in the first or second position when the magnetic field strengthexceeds a second threshold value lower than the first threshold value.

In particular embodiments, the sensor includes two magnetic detectorsand the circuitry detects the first position when the field strengthdetected by the first detector is equal to the field strength detectedby the second detector indicating that the magnet is equidistant fromthe first and second magnetic detectors

In particular embodiments, the cap has two magnets disposed with anangular separation with respect to the axis of the cap and the infusionpump has three sensors, the first of which is positioned adjacent themagnet when the cap is in the first position and separated when the capis in the second position and the second and third sensors beingpositioned to be angularly equidistant from the second magnet when thecap is in the first position, and the circuitry is arranged to detectthe first position when the magnetic field strength exceeds a firstthreshold value as detected by the first sensor and when the magneticfield strength as detected by the second and third sensor are equal.

In particular embodiments, the cap has three magnets spaced at an angleθ and the infusion pump has four sensors, a first being positionedadjacent a first sensor when the cap is in the first position. In suchembodiments, the sensors are spaced at an angle θ, the magnets arepositioned with respect to the first magnet at angles of a half (2n+1)θ, where n represents consecutive integers 1, 2, 3, etc., and saidmagnets alternate in polarity for successive values of n. In suchembodiments, the circuitry is arranged to detect the first position whenthe magnetic field strength detected by the first sensor is a maximum,and the sum of the magnetic field strength for the other sensors equalzero.

Particular embodiments further include a second replaceable reservoirpositionable within the reservoir receptacle in place of the firstreplaceable reservoir, wherein the magnetic fields of the magnets of thefirst and second replaceable reservoirs have different orientations, thesensor is arranged to be able to detect the different orientation whenthe second replaceable reservoir is in the first position, and thecircuitry is configured to indicate that the second replaceablereservoir is in the infusion pump rather than the first replaceablereservoir.

In particular embodiments, the different orientation is a reversal ofthe polarity of the magnetic field. In particular embodiments, thedifferent orientation is a change in the plane of magnetization of themagnetic field.

In particular embodiments, the sensor includes a Hall effect device. Inparticular embodiments, the sensor includes an AMR angle sensor.

Inductive Detection

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device having a reservoir receptaclefor receiving a reservoir containing an infusion media, and forselectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, where infusionpump device includes at least one inductive sensor element. The infusionpump system embodiment further includes a connector interface system forconnecting the reservoir with the infusion pump device. In particularembodiments, a connector interface system includes a cap to connect tothe reservoir to form a reservoir/cap unit for installation into aninfusion pump device, and where at least one inductively detectablefeature is provided on the cap or the reservoir for detection by the atleast one inductive sensor element on the infusion pump when thereservoir of the reservoir/cap unit is received in the reservoirreceptacle of the infusion pump device. The at least one inductivelydetectable feature includes at least one electrically conductivematerial. In further embodiments, the connector interface systemincludes the reservoir to be received within the reservoir receptacle ofthe infusion pump device, where the reservoir contains or is to containinfusion media to be selectively dispensed from the reservoir when thereservoir is received within the reservoir receptacle. In furtherembodiments, the connector interface system includes an infusion setcoupled to the cap via a tubing for conveying infusion media dispensedfrom the reservoir.

In further embodiments, the at least one inductively detectable featurehas at least one detectable parameter including one or more of: theexistence of one or more inductively detectable features, proximity ofthe at least one inductively detectable feature relative to the at leastone sensor element, a size of the at least one inductively detectablefeature, a shape of the at least one inductively detectable feature, amaterial of the at least one inductively detectable feature, a patternof locations of one or more inductively detectable features, or thenumber of inductively detectable features.

In further embodiments, the at least one inductively detectable featureincludes a plurality of inductively detectable features arranged atdifferent respective locations on the cap.

In particular embodiments, the at least one inductively detectablefeature includes a plurality of inductively detectable features inlocations that allow the inductively detectable features to inductivelyinteract with the at least one sensor element to provide detectablesignals for detection of axial or rotational motion or position of thecap or the reservoir relative to the reservoir receptacle, when thereservoir/cap unit is received in the reservoir receptacle.

In further embodiments, the cap includes a housing having an opening forreceiving a portion of the reservoir, the opening defining a centralaxis, and wherein the at least one inductively detectable featureincludes at least one electrically conductive body having a ring shapeor partial ring shape arranged around the central axis.

In further embodiments, the at least one inductively detectable featureincludes at least one electrically conductive body having a first endand a second end, the first end of the electrically conductive bodyhaving a smaller dimension than the second end of the electricallyconductive body.

In further embodiments, the at least one electrically conductive body isarranged on or in the cap in a position such that a predefined one ofthe first and second ends of the electrically conductive body moves in apredefined direction relative to the at least one sensor, followed bythe other of the first and second ends of the electrically conductivebody, as the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device.

In further embodiments, the at least one electrically conductive bodyhas a triangular shape or an arrow-head shape.

In further embodiments, the at least one sensor element includes atleast one electrically conductive coil provided on or in the infusionpump device, at a location at which the at least one electricallyconductive body induces a detectable change in a current flow in the atleast one electrically conductive coil, as the reservoir of thereservoir/cap unit is received in the reservoir receptacle of theinfusion pump device.

In further embodiments, the at least one sensor element includes atleast one electrically conductive coil provided around an axis of thereservoir receptacle of the infusion pump device.

In further embodiments, the at least one sensor element includes atleast one electrically conductive coil provided in a ring-shaped membercoupled to one end of the reservoir receptacle of the infusion pumpdevice.

In further embodiments, the infusion pump device includes electronicsfor controlling the selective dispensing of infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, the electronics configured to inhibit dispensing of infusionmedia from the reservoir unless the at least one inductively detectablefeature is detected by the at least one sensor element.

A connector interface for connecting a reservoir containing an infusionmedia with an infusion pump device according to a further embodimentincludes a cap configured to connect to the reservoir to form areservoir/cap unit, and at least one inductively detectable featurearranged on the cap or the reservoir for detection by at least oneinductive sensor element on the infusion pump device when the reservoirof the reservoir/cap unit is received in the reservoir receptacle of theinfusion pump device.

In further embodiments of such connector interface, the at least oneinductively detectable feature has at least one detectable parameterthat is associated in a table or other data arrangement with one or morecharacteristics of the cap, reservoir or infusion pump device.

In further embodiments of such connector interface, the at least onedetectable parameter includes one or more of: a proximity or distancebetween the one or more electrically conductive targets and the one ormore coils, or the size, shape, material location or pattern oflocations of the one or more electrically conductive targets.

In further embodiments of such connector interface, the at least onedetectable parameter of the inductively detectable feature provides adetectable signature that indicates the presence of a reservoir/cap unitin a fully installed position within reservoir receptacle, orinformation associated with the cap, the reservoir or the reservoir/capunit.

In further embodiments of such connector interface, the detectableparameter of the of at least one inductively detectable feature isassociated with one or more characteristics that include one or more of:a type or identity of a manufacturer of the reservoir, cap or infusionpump device; a size of the reservoir, cap or infusion pump device; atype or concentration of infusion media in the reservoir; a volumeamount of infusion media in the reservoir; a date corresponding to amanufacturing date, expiration date or fill date related to infusionmedia in the reservoir; a date corresponding to a manufacturing date orexpiration date of the reservoir, cap or infusion pump device; alocation corresponding to a place where the reservoir or infusion mediain the reservoir was made, filled, or otherwise processed; a locationcorresponding to a place where the cap or infusion pump device was made,assembled or otherwise processed; a location corresponding to a placewhere the reservoir, infusion media in the reservoir, cap or infusionpump device is authorized to be used; a lot number or code associatedwith a batch in which the reservoir, cap, infusion pump device orinfusion media was made, cleaned, filled or otherwise processed; aserial number; a unique ID; user identification information forauthorized users.

In further embodiments of such connector interface, the at least oneinductively detectable feature includes: (a) one or more electricallyconductive targets in one or more locations for inductive interactionwith the one or more coils when the reservoir/cap unit is received inthe reservoir receptacle; or (b) a plurality of electrically conductivetargets in locations that allow the one or more electrically conductivetargets to inductively interact with the one or more coils to providedetectable signals for detection of axial or rotational motion orposition of the cap or the reservoir relative to the reservoirreceptacle, when the reservoir/cap unit is received in the reservoirreceptacle.

In further embodiments of such connector interface, the at least oneinductively detectable feature includes: (a) one or more electricallyconductive targets on the cap or the reservoir; (b) one or moreelectrically conductive targets supported by one or more moveablesupport structures on the infusion pump device for engagement with anengagement portion on the cap or the reservoir and for linear movementwith the cap or the reservoir upon the cap or the reservoir beingreceived in the reservoir receptacle of the infusion pump device, wherethe engagement portion is provided at a predefined location on the capor the reservoir to provide a predefined amount of movement of anelectrically conductive target relative to a predefined coil, where theengagement portion includes one or more protrusions, bumps, extensions,ramps or depressions; (c) one or more electrically conductive targetssupported on one or more moveable members supported in one or morechannels in the infusion pump device, where each moveable member has oneend arranged in a location to be contacted by an engagement portion ofthe cap or the reservoir upon the cap or the reservoir being received inthe reservoir receptacle, to move the moveable member and electricallyconductive target supported thereon from a first position to a secondposition in a direction of a longitudinal dimension of the channel asthe cap or the reservoir is received in the reservoir receptacle, whereeach moveable member is biased by a bias spring toward the firstposition, and where each moveable member includes one or more seals forsealing with an inner surface of a channel; or (d) a structure mountedon a piston inside the reservoir.

In further embodiments of such connector interface, the one or more orplurality of electrically conductive targets include: (a) at least onemetallic ring or band on the cap or the reservoir that extendscircumferentially around an axis of the cap or the reservoir; (b) atleast one electrically conductive target having a predefined shape, sizeor conductive characteristic that provides a predetermined inductionsignature; (c) at least one electrically conductive target having atriangular shape, tapered shape or arrow-head shape with one end that iswider than an opposite end to provide a time varying induction signaturewhen the at least one electrically conductive target is moved relativeto the at least one inductive sensor; (d) a plurality of electricallyconductive targets having the same shape relative to each other; (e) aplurality of electrically conductive targets having different shapesrelative to each other; or (f) a plurality of electrically conductivetargets arranged in a pattern to provide a predetermined inductionsignature.

In further embodiments of such connector interface, the one or more orplurality of electrically conductive targets are: (a) attached to anouter surface of the cap or the reservoir, (b) attached to an innersurface of the cap or the reservoir, or (c) embedded within a wall ofthe cap or the reservoir.

An infusion pump system according to further embodiments includes aconnector interface as described in any of the preceding paragraphs andan infusion pump device having a reservoir receptacle for receiving thereservoir, and for selectively dispensing the infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, wherein the infusion pump device includes at least oneinductive sensor element for detecting the inductively detectablefeature.

In further embodiments of such infusion pump system, the infusion pumpdevice includes electronics for controlling the selective dispensing ofinfusion media from the reservoir when the reservoir is received withinthe reservoir receptacle, the electronics configured to inhibitdispensing of infusion media from the reservoir unless the at least oneinductively detectable feature is detected by the at least one inductivesensor element.

In further embodiments of such infusion pump system, the electronics areconnected with a memory that stores the table or other data arrangement,and the electronics are configured to control the selective dispensingof infusion media from the reservoir when the reservoir is receivedwithin the reservoir receptacle, the selective dispensing being based,at least in part on the one or more characteristics associated in thetable or other data arrangement with the at least one detectableparameter of the inductively detectable feature.

In further embodiments of such infusion pump system, the electronics areconfigured to record information in the memory, the informationcorresponding to: (a) at least one detectable parameter detected by theat least one inductive sensor, or (b) at least one characteristicassociated in the table or other data arrangement with at least onedetectable parameter detected by the at least one inductive sensor.

In further embodiments of such infusion pump system, the electronics arefurther configured to record location information corresponding to ageographic location of the infusion pump device when the at least onedetectable parameter of the inductively detectable feature is detected.

In further embodiments of such infusion pump system, the electronics arefurther configured to record time information corresponding to a time ordate when the at least one detectable parameter is detected.

In further embodiments of such infusion pump system, the at least oneinductive sensor includes one or more electrically conductive coils onthe infusion pump device, the one or more electrically conductive coilsbeing electrically connected with an electrical circuit that is coupledto processing electronics configured to detect electrical inductioneffects in the electrical circuit caused by movement or proximity of theat least one inductively detectable feature relative to the one or moreelectrically conductive coils.

In further embodiments of such infusion pump system, (a) the at leastone inductively detectable feature is arranged on the cap, the reservoiror the infusion pump device, at a location to be detected by the atleast one inductive sensor element when the reservoir/cap unit is fullyreceived in the reservoir receptacle of the infusion pump device, butnot detected by the at least one inductive sensor element when thereservoir/cap unit is not fully received in the reservoir receptacle ofthe infusion pump device; or (b) the cap includes at least one threadarranged to engage a corresponding thread or groove in the infusion pumpdevice when the reservoir/cap unit is received in the reservoirreceptacle of the infusion pump device, wherein the at least oneinductively detectable feature is located on the at least one thread.

An infusion pump system according to a further embodiment includes aninfusion pump device having a reservoir receptacle for receiving areservoir containing an infusion media, and for selectively dispensinginfusion media from the reservoir when the reservoir is received withinthe reservoir receptacle, wherein the infusion pump device includes atleast one inductive sensor. The infusion pump system further includes aconnector interface for connecting the reservoir with the infusion pumpdevice, wherein the connector interface has a cap configured to connectto the reservoir to form a reservoir/cap unit, said reservoir/cap unithaving an identifying pattern of engagement members. The infusion pumpsystem further includes inductively detectable target members inside thereservoir receptacle and disposed to be engaged by respective one of theengagement members to move the target members into detectable proximityto the inductive sensor, thereby detecting the identifying pattern ofengagement members when the reservoir of the reservoir/cap unit isreceived in the reservoir receptacle of the infusion pump device.

In further embodiments of the above-described infusion pump system, theidentifying pattern of engagement members represents one or more of thefollowing characteristics: a type or identity of a manufacturer of thereservoir, cap or infusion pump device; a size of the reservoir, cap orinfusion pump device; a type or concentration of infusion media in thereservoir; a volume amount of infusion media in the reservoir; a datecorresponding to a manufacturing date, expiration date or fill daterelated to infusion media in the reservoir; a date corresponding to amanufacturing date or expiration date of the reservoir, cap or infusionpump device; a location corresponding to a place where the reservoir orinfusion media in the reservoir was made, filled, or otherwiseprocessed; a location corresponding to a place where the cap or infusionpump device was made, assembled or otherwise processed; a locationcorresponding to a place where the reservoir, infusion media in thereservoir, cap or infusion pump device is authorized to be used; a lotnumber or code associated with a batch in which the reservoir, cap,infusion pump device or infusion media was made, cleaned, filled orotherwise processed; a serial number; a unique ID; user identificationinformation for authorized users; and the infusion pump system containselectronics including a memory that stores a table associating saidcharacteristics with identifying patterns of engagement members, and theelectronics are configured to control the selective dispensing ofinfusion media from the reservoir when the reservoir is received withinthe reservoir receptacle, the selective dispensing being based, at leastin part on the one or more characteristics associated in the table withthe detected identifying pattern.

An infusion pump device according to a further embodiment includes areservoir receptacle for receiving the reservoir, and for selectivelydispensing infusion media from the reservoir when the reservoir isreceived within the reservoir receptacle. The infusion pump devicefurther includes at least one inductive sensor element for detecting theinductively detectable feature on the reservoir, representing itscontents or characteristics of any tubing or infusion set connectedthereto. The infusion pump device further includes electronics connectedto the at least one sensor element and configured to control saidselective dispensing at least partially in accordance with said detectedfeature.

Further embodiments include a method of configuring an infusion pumpdevice having a reservoir receptacle for receiving a reservoircontaining an infusion media, and for selectively dispensing infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, there being provided a connector interface forconnecting the reservoir with the infusion pump device, wherein theconnector interface has a cap configured to connect to the reservoir toform a reservoir/cap unit. The method includes providing thereservoir/cap unit with an inductively detectable feature containingdata required to configure the pump for that particular reservoir/capunit when the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device; detecting theinductively detectable feature using an inductive sensor on the pump;and configuring the pump in accordance with the detected data.

RF Detection

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device having a reservoir receptaclefor receiving a reservoir containing an infusion media, and forselectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, where infusionpump device includes at least one Radio Frequency (RF) sensor (e.g., atransmitter/receiver) element. The infusion pump system embodimentfurther includes a connector interface system for connecting thereservoir with the infusion pump device. A connector interface systemaccording to an embodiment of the present invention has a cap configuredto connect to the reservoir to form a reservoir/cap unit forinstallation into an infusion pump device, and where at least one RFdetectable feature is provided on the cap or the reservoir for detectionby the at least one RF sensor element on the infusion pump device whenthe reservoir of the reservoir/cap unit is received in the reservoirreceptacle of the infusion pump device. In further embodiments, theconnector interface system includes the reservoir to be received withinthe reservoir receptacle of the infusion pump device, where thereservoir contains or is to contain infusion media to be selectivelydispensed from the reservoir when the reservoir is received within thereservoir receptacle. In further embodiments, the connector interfacesystem includes an infusion set coupled to the cap via a tubing forconveying infusion media dispensed from the reservoir.

In particular embodiments, the at least one RF detectable feature has atleast one detectable parameter that is associated with one or morecharacteristics of the cap, the reservoir, a cannula, or a tubingconnected between the cap and the cannula.

In particular embodiments, the at least one detectable parameterincludes one or more of: the existence of one or more RF detectablefeatures on the cap or the reservoir; the location or pattern oflocations of one or more RF detectable features on the cap or thereservoir; the type of RF detectable feature on the cap or thereservoir; the type or content of data stored by the RF detectablefeature; the polarity, direction or orientation, RSSI or other RF signalstrength, or amplitude or phase of an RF signal from the RF detectablefeature.

In particular embodiments, the detectable parameter of the of at leastone RF detectable feature is associated with one or more characteristicsthat include one or more of: a type or identity of a manufacturer of thereservoir or the cap; a size of the reservoir or the cap; a type orconcentration of infusion media in the reservoir; a volume amount ofinfusion media in the reservoir; a date corresponding to a manufacturingdate, expiration date, or fill date related to infusion media in thereservoir; a date corresponding to a manufacturing date or expirationdate of the reservoir or the cap; a location corresponding to a placewhere the reservoir or infusion media in the reservoir was made, filled,or otherwise processed; a location corresponding to a place where thecap was made, assembled, or otherwise processed; a locationcorresponding to a place where the reservoir, infusion media in thereservoir, or the cap is authorized to be used; a lot number or codeassociated with a batch in which the reservoir, the cap, or infusionmedia was made, cleaned, filled, or otherwise processed; a serialnumber; a unique ID; user identification information for authorizedusers; a type, length, or size of the cannula; or a type, length, orsize of the tubing connected between the cap and the cannula.

In further embodiments, the at least one RF detectable feature includesa plurality of RF detectable features arranged at different respectivelocations on the cap.

In further embodiments, the at least one RF detectable feature includesa plurality of RF detectable features in locations that allow the RFdetectable features to interact with the at least one RF sensor elementto provide detectable signals for detection of axial or rotationalmotion or position of the cap or the reservoir relative to the reservoirreceptacle, when the reservoir/cap unit is received in the reservoirreceptacle.

In further embodiments, the at least one RF detectable feature includesa radio frequency identification (RFID) tag that is attached to the cap.

In further embodiments, the at least one RF detectable feature includesa passive RF device that receives power through inductive coupling withthe at least one RF sensor element.

In further embodiments, the at least one RF detectable feature includesan RF detectable device having a directional antenna or an antenna withat least one RF shield or wave guide configured to direct RF signals toor from the antenna.

In further embodiments, the at least one RF detectable feature has amemory that stores information, and an antenna for communicatinginformation stored in the memory, the memory includes a first sectionthat stores permanent information and a second section that is writeablefor storing information written to the RF detectable feature.

In further embodiments, the information stored in the memory includesinformation identifying one or more of: a type or identity of amanufacturer of the reservoir; a size of the reservoir; a type orconcentration of infusion media in the reservoir; a volume amount ofinfusion media in the reservoir; a volume amount of infusion media thathas been dispensed from the reservoir; a date corresponding to anexpiration date or fill date related to infusion media in the reservoir;a location corresponding to a place where the reservoir or infusionmedia in the reservoir was made, filled, or otherwise processed; a lotnumber or code associated with a batch in which the reservoir orinfusion media was made, cleaned, filled or otherwise processed.

In further embodiments, the information stored in the memory includesinformation identifying one or more characteristics relating to aninfusion set connected to the cap, the one or more characteristicsincluding at least one of: a type or identity of a manufacturer of theinfusion set; a length of tubing in the infusion set; a diameter of thetubing in the infusion set; a length of a needle or cannula in theinfusion set; a diameter of the needle or cannula in the infusion set; adate corresponding to an expiration date, manufacturing date or assemblydate of the infusion set; a location corresponding to a place where theinfusion set was made or assembled; a lot number or other codeassociated with a batch in which the infusion set was made, cleaned orotherwise processed.

In further embodiments, the information stored in the memory includesinformation identifying one or more characteristics of the connectorinterface, the one or more characteristics including at least one of atype or manufacturer of the connection interface; a size dimension ofthe cap; a date corresponding to an expiration date, manufacturing dateor assembly date of the connector interface; a location corresponding tothe place where the connector interface was made or assembled; a lotnumber or other code associated with a batch in which the connectorinterface was made, cleaned or otherwise processed.

In further embodiments, the infusion set further includes a cannula, andwherein the at least one RF detectable feature has at least onedetectable parameter that is associated with one or more characteristicsof the cannula or the tubing of the infusion set.

In further embodiments, the characteristic of the cannula or the tubingof the infusion set includes a size or length of the cannula, or a sizeor length of the tubing.

In further embodiments, the infusion pump device includes electronicsconnected with an electronic memory, the electronics and electronicmemory are configured to control the selective dispensing of infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, the selective dispensing being based, at least inpart on the one or more characteristics associated with the at least onedetectable parameter in a table or other data arrangement stored in theelectronic memory.

In further embodiments, the infusion pump device includes electronicsconfigured to record information in a memory, the informationcorresponding to one or more of: (a) at least one detectable parameterdetected by the at least one RF sensor, (b) at least one characteristicassociated with at least one detectable parameter detected by the atleast one RF sensor, (c) location information corresponding to ageographic location of the infusion pump device when the at least onedetectable parameter is detected, or (d) time information correspondingto a time or date when the at least one detectable parameter isdetected.

In further embodiments, the infusion pump device includes electronicsfor controlling the selective dispensing of infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, the electronics configured to inhibit dispensing of infusionmedia from the reservoir unless the at least one RF detectable featureis detected by the RF sensor element.

A connector interface for connecting a reservoir containing an infusionmedia with an infusion pump device according to a further embodimentincludes a cap configured to connect to the reservoir to form areservoir/cap unit. At least one RF detectable feature is arranged onthe cap or the reservoir for detection by at least one RF sensor elementwhen the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device.

In further embodiments: (a) the at least one RF detectable featureincludes a radio frequency identification (RFID) tag that is attached toa housing of the cap to the reservoir or on a plunger within thereservoir, (b) the at least one RF detectable feature includes a passiveRF device that receives power through inductive coupling with the RFsensor, (c) the at least one RF detectable feature includes an RFdetectable device having a directional antenna or an antenna with atleast one RF shield or wave guide configured to direct RF signals to orfrom the antenna, (d) the at least one RF detectable feature includes anRF detectable device having an antenna, the antenna being arrangedadjacent or in a vent opening on the cap, and (e) the at least one RFdetectable feature includes an antenna printed with conductive ink onthe cap, the reservoir, or a label applied to the reservoir or cap; or(f) the at least one RF detectable feature has a memory that storesinformation, and an antenna for communicating information stored in thememory, the memory includes a first section that stores permanentinformation and a second section that is writeable for storinginformation written to the RF detectable feature, where: (i) theinformation stored in the memory includes information identifying one ormore of: a type or identity of a manufacturer of the reservoir; a sizeof the reservoir; a type or concentration of infusion media in thereservoir; a volume amount of infusion media in the reservoir; a volumeamount of infusion media that has been dispensed from the reservoir; adate corresponding to an expiration date or fill date related toinfusion media in the reservoir; a location corresponding to a placewhere the reservoir or infusion media in the reservoir was made, filled,or otherwise processed; a lot number or code associated with a batch inwhich the reservoir or infusion media was made, cleaned, filled orotherwise processed; (ii) the information stored in the memory includesinformation identifying one or more characteristics relating to aninfusion set connected to the cap, the one or more characteristicsincluding at least one of: a type or identity of a manufacturer of theinfusion set; a length of tubing in the infusion set; a diameter of thetubing in the infusion set; a length of a needle or cannula in theinfusion set; a diameter of the needle or cannula in the infusion set; adate corresponding to an expiration date, manufacturing date or assemblydate of the infusion set; a location corresponding to a place where theinfusion set was made or assembled; a lot number or other codeassociated with a batch in which the infusion set was made, cleaned orotherwise processed; or (iii) the information stored in the memoryincludes information identifying one or more characteristics of theconnector interface, the one or more characteristics including at leastone of a type or manufacturer of the connection interface; a sizedimension of the cap; a date corresponding to an expiration date,manufacturing date or assembly date of the connector interface; alocation corresponding to the place where the connector interface wasmade or assembled; a lot number or other code associated with a batch inwhich the connector interface was made, cleaned or otherwise processed.

In further embodiments, the at least one RF detectable feature has atleast one detectable parameter that is associated with one or morecharacteristics of the cap, reservoir, downstream structure, or infusionpump device.

In further embodiments, the at least one RF detectable feature has atleast one detectable parameter including one or more of: the existenceof one or more RF detectable feature(s) on the cap or the reservoir; thelocation or pattern of locations of one or more RF detectable featureson the cap or the reservoir; the type of RF detectable feature on thecap or the reservoir; the type or content of data stored by the RFdetectable feature; the polarity, direction or orientation, RSSI orother RF signal strength, amplitude or phase of an RF signal from the RFdetectable feature.

In further embodiments, the at least one RF detectable feature has atleast one detectable parameter that is associated with one or morecharacteristics that include one or more of: a type or identity of amanufacturer of the reservoir, cap or infusion pump device; a size ofthe reservoir, cap or infusion pump device; a type or concentration ofinfusion media in the reservoir; a volume amount of infusion media inthe reservoir; a date corresponding to a manufacturing date, expirationdate or fill date related to infusion media in the reservoir; a datecorresponding to a manufacturing date or expiration date of thereservoir, cap or infusion pump device; a location corresponding to aplace where the reservoir or infusion media in the reservoir was made,filled, or otherwise processed; a location corresponding to a placewhere the cap or infusion pump device was made, assembled or otherwiseprocessed; a location corresponding to a place where the reservoir,infusion media in the reservoir, cap or infusion pump device isauthorized to be used; a lot number or code associated with a batch inwhich the reservoir, cap, infusion pump device or infusion media wasmade, cleaned, filled or otherwise processed; a serial number; a uniqueID; user identification information for authorized users.

In further embodiments, an infusion pump system includes a connectorinterface as described in any of the preceding paragraphs and aninfusion pump device having a reservoir receptacle for receiving thereservoir, and for selectively dispensing infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, wherein the infusion pump device includes at least one RadioFrequency (RF) sensor (e.g., a transmitter/receiver) element to detectthe reservoir in the reservoir receptacle.

In further embodiments, the infusion pump device includes electronicsfor controlling the selective dispensing of infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, the electronics being configured to inhibit dispensing ofinfusion media from the reservoir unless the at least one RF detectablefeature is detected by the RF sensor element.

In further embodiments, electronics are provided connected with a memorythat stores a table or other data arrangement, and the electronics areconfigured to control the selective dispensing of infusion media fromthe reservoir when the reservoir is received within the reservoirreceptacle, the selective dispensing being based, at least in part onthe one or more characteristics associated in the table or other dataarrangement with the at least one detectable parameter of the RFdetectable feature.

In further embodiments, the electronics are configured to recordinformation in the memory, the information corresponding to: (a) atleast one detectable parameter detected by the at least one RF sensor,or (b) at least one characteristic associated in the table or other dataarrangement with at least one detectable parameter detected by the atleast one RF sensor.

In further embodiments, the electronics are further configured to recordlocation information corresponding to a geographic location of theinfusion pump device when the at least one detectable parameter of theRF detectable feature is detected.

In further embodiments, the at least one RF detectable feature includes:(a) one or more RF detectable features in one or more locations for RFinteraction with the at least one RF sensor when the reservoir/cap unitis received in the reservoir receptacle; or (b) a plurality of RFdetectable features in locations that allow the one or more of the RFdetectable features to interact with the at least one RF sensor toprovide detectable signals for detection of axial or rotational motionor position of the cap or the reservoir relative to the reservoirreceptacle, when the reservoir/cap unit is received in the reservoirreceptacle.

An infusion pump system according to a further embodiment includes aninfusion pump device having a reservoir receptacle for receiving areservoir containing an infusion media, and for selectively dispensinginfusion media from the reservoir when the reservoir is received withinthe reservoir receptacle. The infusion pump system further includes aconnector interface for connecting the reservoir with the infusion pumpdevice wherein the connector interface has a cap configured to connectto the reservoir to form a reservoir/cap unit, said reservoir/cap unitcontaining an RFID chip. The RFID chip contains data representing one ormore of the following characteristics: a type or identity of amanufacturer of the reservoir, cap or infusion pump device; a size ofthe reservoir, cap or infusion pump device; a type or concentration ofinfusion media in the reservoir; a volume amount of infusion media inthe reservoir; a date corresponding to a manufacturing date, expirationdate or fill date related to infusion media in the reservoir; a datecorresponding to a manufacturing date or expiration date of thereservoir, cap or infusion pump device; a location corresponding to aplace where the reservoir or infusion media in the reservoir was made,filled, or otherwise processed; a location corresponding to a placewhere the cap or infusion pump device was made, assembled or otherwiseprocessed; a location corresponding to a place where the reservoir,infusion media in the reservoir, cap or infusion pump device isauthorized to be used; a lot number or code associated with a batch inwhich the reservoir, cap, infusion pump device or infusion media wasmade, cleaned, filled or otherwise processed; a serial number; a uniqueID; user identification information for authorized users. The infusionpump system further includes a structure on the infusion pump device fordetecting reception of the reservoir in the reservoir receptacle. Theinfusion pump system contains electronics connected to the receptiondetecting structure and having circuitry to interrogate the RFID chip toread characteristics therefrom to control the selective dispensing ofinfusion media from the reservoir (1) when the reservoir is detected asreceived within the reservoir receptacle, the selective dispensing beingbased, at least in part on the characteristics read from the RFID chip.

In further embodiments, an infusion pump device has a reservoirreceptacle for receiving a reservoir containing an infusion media, andfor selectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle; an RFID chipreader configured to read data from an RFID chip on the reservoir, thedata representing the contents of the reservoir or characteristics ofany tubing or infusion set connected thereto; and electronics connectedto the RFID reader and configured to control said selective dispensingat least partially in accordance with said read data.

Further embodiments include a method of configuring an infusion pumpdevice having a reservoir receptacle for receiving a reservoircontaining an infusion media, and for selectively dispensing infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, there being provided a connector interface forconnecting the reservoir with the infusion pump device, wherein theconnector interface has a cap configured to connect to the reservoir toform a reservoir/cap unit. In such embodiments, the method includesproviding the reservoir/cap unit with an RFID chip containing datarequired to configure the pump for that particular reservoir/cap unitwhen the reservoir (1) of the reservoir/cap unit is received in thereservoir receptacle (32) of the infusion pump device (30);interrogating the RFID chip to obtain the data; and configuring the pumpin accordance with the detected data.

Mechanical Detection

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device having a reservoir receptaclefor receiving a reservoir containing an infusion media, and forselectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, where infusionpump device includes at least one mechanical detection sensor element.The infusion pump system embodiment further includes a connectorinterface system for connecting the reservoir with the infusion pumpdevice. A connector interface system according to an embodiment has acap configured to connect to the reservoir to form a reservoir/cap unit,and where at least one mechanically detectable feature is arranged onthe cap or the reservoir for detection by the at least one sensorelement when the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device. In furtherembodiments, the connector interface system includes the reservoir to bereceived within the reservoir receptacle of the infusion pump device,where the reservoir contains or is to contain infusion media to beselectively dispensed from the reservoir when the reservoir is receivedwithin the reservoir receptacle. In further embodiments, the connectorinterface system includes an infusion set coupled to the cap via atubing for conveying infusion media dispensed from the reservoir.

In further embodiments, the at least one mechanically detectable featureincludes a plurality of mechanically detectable features arranged atdifferent respective locations on the cap.

In further embodiments, the at least one mechanically detectable featureincludes a plurality of mechanically detectable features in locationsthat allow the mechanically detectable features to mechanically interactwith the at least one sensor element to provide detectable signals fordetection of axial or rotational motion or position of the cap or thereservoir relative to the reservoir receptacle, when the reservoir/capunit is received in the reservoir receptacle.

In further embodiments, the at least one mechanically detectable featureis arranged on the cap or on the reservoir, at a location to be detectedby the at least one sensor element when the reservoir/cap unit is fullyreceived in the reservoir receptacle of the infusion pump device, butnot detected by the at least one sensor element when the reservoir/capunit is not fully received in the reservoir receptacle of the infusionpump device.

In further embodiments, the at least one mechanically detectable featureincludes at least one protrusion on an outer surface of the cap or thereservoir.

In further embodiments, the at least one mechanically detectable featureincludes a plurality of protrusions at mutually different locations onthe cap or the reservoir.

In further embodiments, the at least one mechanically detectable featureincludes first and second protrusions located about 180 degrees fromeach other with respect to a central axis through the reservoir/capunit.

In further embodiments, the infusion pump device includes electronicsfor controlling the selective dispensing of infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, the electronics configured to inhibit dispensing of infusionmedia from the reservoir unless the at least one mechanically detectablefeature is detected by the at least one sensor element.

In further embodiments, the at least one sensor element includes atleast one moveable actuator arranged on the infusion pump device, andwherein the at least one mechanically detectable feature is provided onat least one predefined location of the cap or the reservoir, forengagement with at least one moveable actuator on the infusion pumpdevice when the reservoir/cap unit is fully received in the reservoirreceptacle of the infusion pump device.

In further embodiments, the infusion pump device has a housing portionin which a channel is located. The channel has a longitudinal dimensionand is open to the reservoir receptacle on one end of its longitudinaldimension. In such embodiments, the at least one moveable actuatorincludes a moveable member arranged within the channel. The moveablemember has a first end arranged within the housing portion of theinfusion pump device, and a second end arranged to extend through theopen end of the channel and into the reservoir receptacle for engagingthe cap or the reservoir when the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device.

In particular embodiments, the moveable member is made of a compressiblematerial that compresses in at least one dimension and expands in atleast one other dimension when the second end of the moveable member isengaged by the cap or the reservoir as the reservoir/cap unit isreceived in the reservoir receptacle of the infusion pump device.

In further embodiments, the at least one sensor element includes anelectrical switch located in the infusion pump device housing, whereinthe first end of the moveable member is arranged adjacent the electricalswitch, and wherein the moveable member is arranged to activate theelectrical switch when the moveable member expands in said otherdimension

In further embodiments, the moveable member includes at least one sealfor sealing the channel to inhibit the passage of fluid through thechannel, where the at least one seal includes at least one sealstructure on the moveable member and that engages an inner surface ofthe channel.

A connector interface for connecting a reservoir containing an infusionmedia with an infusion pump device according to a further embodimentincludes a cap configured to connect to the reservoir to form areservoir/cap unit, and wherein at least one mechanically detectablefeature is arranged on the cap or the reservoir for detection by atleast one sensor element on the pump device when the reservoir of thereservoir/cap unit is received in the reservoir receptacle of theinfusion pump device.

In further embodiments, the at least one mechanically detectable featureincludes at least one protrusion on an outer surface of the cap or thereservoir, a plurality of protrusions at mutually different locations onthe cap or the reservoir, or first and second protrusions located about180 degrees from each other with respect to a central axis through thecap or the reservoir.

In further embodiments, (a) the at least one mechanically detectablefeature includes a plurality of mechanically detectable featuresarranged at different respective locations on the cap or the reservoir;(b) the at least one mechanically detectable feature is arranged on thecap or on the reservoir, at a location to be detected by the at leastone sensor element when the reservoir/cap unit is fully received in thereservoir receptacle of the infusion pump device, but not detected bythe at least one sensor element when the reservoir/cap unit is not fullyreceived in the reservoir receptacle of the infusion pump device; (c)the at least one mechanically detectable feature includes a plurality ofmechanically detectable features in locations that allow themechanically detectable features to mechanically interact with the atleast one sensor element to provide detectable signals for detection ofaxial or rotational motion or position of the cap or the reservoirrelative to the reservoir receptacle, when the reservoir/cap unit isreceived in the reservoir receptacle; or (d) the cap includes at leastone thread arranged to engage a corresponding thread or groove in theinfusion pump device when the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device, wherein the at leastone mechanically detectable feature is located on the at least onethread.

In further embodiments, the at least one mechanically detectable featurehas at least one detectable parameter that is associated with one ormore characteristics of the cap, reservoir or infusion pump device.

In further embodiments, the at least one detectable parameter includesone or more of: the existence of one or more mechanically detectablefeature on the cap or the reservoir; the location or pattern oflocations of one or more mechanically detectable features on the cap orthe reservoir; or the size or shape of the mechanically detectablefeature on the cap or the reservoir.

In further embodiments, the detectable parameter of the of at least onemechanically detectable feature is associated with one or morecharacteristics that include one or more of: a type or identity of amanufacturer of the reservoir, cap or infusion pump device; a size ofthe reservoir, cap or infusion pump device; a type or concentration ofinfusion media in the reservoir; a volume amount of infusion media inthe reservoir; a date corresponding to a manufacturing date, expirationdate or fill date related to infusion media in the reservoir; a datecorresponding to a manufacturing date or expiration date of thereservoir, cap or infusion pump device; a location corresponding to aplace where the reservoir or infusion media in the reservoir was made,filled, or otherwise processed; a location corresponding to a placewhere the cap or infusion pump device was made, assembled or otherwiseprocessed; a location corresponding to a place where the reservoir,infusion media in the reservoir, cap or infusion pump device isauthorized to be used; a lot number or code associated with a batch inwhich the reservoir, cap, infusion pump device or infusion media wasmade, cleaned, filled or otherwise processed; a serial number; a uniqueID; user identification information for authorized users.

An infusion pump system according to a further embodiment includes aconnector interface as described in any of the above embodiments, and aninfusion pump device having a reservoir receptacle for receiving thereservoir, and for selectively dispensing infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, wherein the infusion pump device includes at least onemechanical detection sensor element to detect the mechanicallydetectable feature.

In further embodiments of such an infusion pump system, the infusionpump device includes electronics for controlling the selectivedispensing of infusion media from the reservoir when the reservoir isreceived within the reservoir receptacle, the electronics configured toinhibit dispensing of infusion media from the reservoir unless the atleast one mechanically detectable feature is detected by the at leastone sensor element.

In further embodiments of such an infusion pump system, the electronicsare connected with a memory that stores a table or other dataarrangement, and the electronics are configured to control the selectivedispensing of infusion media from the reservoir when the reservoir isreceived within the reservoir receptacle, the selective dispensing beingbased, at least in part on the one or more characteristics associated inthe table or other data arrangement with the at least one detectableparameter of the mechanically detectable feature.

In further embodiments of such an infusion pump system, the electronicsare configured to record information in the memory, where theinformation corresponds to: (a) at least one detectable parameter of themechanically detectable feature detected by the at least one sensor, or(b) at least one characteristic associated in the table or other dataarrangement with at least one detectable parameter of the mechanicallydetectable feature detected by the at least one sensor.

In further embodiments of such an infusion pump system, the electronicsare further configured to record location information corresponding to ageographic location of the infusion pump device when the at least onedetectable parameter of the mechanically detectable feature is detected.

In further embodiments of such an infusion pump system, the electronicsare further configured to record time information corresponding to atime or date when the at least one detectable parameter of themechanically detectable feature is detected.

In further embodiments of such an infusion pump system, the at least onesensor element includes at least one moveable actuator arranged on theinfusion pump device.

In further embodiments of such an infusion pump system, the detectablefeature includes at least one mechanically detectable feature providedon at least one predefined location of the cap or the reservoir, forengagement with at least one moveable actuator on the infusion pumpdevice when the reservoir/cap unit is fully received in the reservoirreceptacle of the infusion pump device.

In further embodiments of such an infusion pump system, the infusionpump device has a housing portion in which a channel is located, thechannel having a longitudinal dimension, the channel being open to thereservoir receptacle on one end of its longitudinal dimension.

In further embodiments of such an infusion pump system, the at least onemoveable actuator includes a moveable member arranged within thechannel, the moveable member having a first end arranged within thehousing portion of the infusion pump device, the moveable member havinga second end arranged to extend through the open end of the channel andinto the reservoir receptacle for engaging the cap or the reservoir whenthe reservoir/cap unit is received in the reservoir receptacle of theinfusion pump device.

In further embodiments of such an infusion pump system, the moveablemember is made of a compressible material that compresses in at leastone dimension and expands in at least one other dimension when thesecond end of the moveable member is engaged by the cap or the reservoiras the reservoir/cap unit is received in the reservoir receptacle of theinfusion pump device.

In further embodiments of such an infusion pump system, the at least onesensor element further includes an electrical switch located in theinfusion pump device housing, wherein the first end of the moveablemember is arranged adjacent the electrical switch, and wherein themoveable member is arranged to activate the electrical switch when themoveable member expands in said other dimension.

In further embodiments of such an infusion pump system, the moveablemember includes at least one seal for sealing the channel to inhibit thepassage of fluid through the channel, the at least one seal including atleast one seal structure on the moveable member and that engages aninner surface of the channel.

An infusion pump system according to a further embodiment includes aninfusion pump device having a reservoir receptacle for receiving areservoir containing an infusion media, and for selectively dispensinginfusion media from the reservoir when the reservoir is received withinthe reservoir receptacle; and a connector interface for connecting thereservoir with the infusion pump device wherein the connector interfacehas a cap configured to connect to the reservoir to form a reservoir/capunit, said reservoir/cap unit having an identifying pattern ofengagement members. The infusion pump device has movable members movablebetween a first position in which the movable members project into thereservoir receptacle and a second retracted position, each movablemember further having an associated electrical switch which is actuatedwhen the movable member is in the retracted position. Each of theengagement members of the pattern of engagement members on thereservoir/cap unit is positioned to engage a respective one of themovable members and move it from the first position to the secondposition when the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device thereby detecting theidentifying pattern of engagement members.

In further embodiments of such an infusion pump system, the identifyingpattern of engagement members represents one or more of the followingcharacteristics: a type or identity of a manufacturer of the reservoir,cap or infusion pump device; a size of the reservoir, cap or infusionpump device; a type or concentration of infusion media in the reservoir;a volume amount of infusion media in the reservoir; a date correspondingto a manufacturing date, expiration date or fill date related toinfusion media in the reservoir; a date corresponding to a manufacturingdate or expiration date of the reservoir, cap or infusion pump device; alocation corresponding to a place where the reservoir or infusion mediain the reservoir was made, filled, or otherwise processed; a locationcorresponding to a place where the cap or infusion pump device was made,assembled or otherwise processed; a location corresponding to a placewhere the reservoir, infusion media in the reservoir, cap or infusionpump device is authorized to be used; a lot number or code associatedwith a batch in which the reservoir, cap, infusion pump device orinfusion media was made, cleaned, filled or otherwise processed; aserial number; a unique ID; user identification information forauthorized users. In addition, the infusion pump system containselectronics connected to the electrical switches including a memory thatstores a table associating said characteristics with identifyingpatterns of engagement members. The electronics are configured tocontrol the selective dispensing of infusion media from the reservoirwhen the reservoir is received within the reservoir receptacle, theselective dispensing being based, at least in part on the one or morecharacteristics associated in the table with the detected identifyingpattern.

An infusion pump device according to a further embodiment has areservoir receptacle for receiving a reservoir containing an infusionmedia, and for selectively dispensing infusion media from the reservoirwhen the reservoir is received within the reservoir receptacle. Theinfusion pump device according to such embodiments further includes atleast one mechanical detection sensor element to detect a mechanicallydetectable feature on the reservoir, representing its contents orcharacteristics of any tubing or infusion set connected thereto. Theinfusion pump device further includes electronics connected to the atleast one sensor element and configured to control said selectivedispensing at least partially in accordance with said detected feature.

Further embodiments include a method of configuring an infusion pumpdevice having a reservoir receptacle for receiving a reservoircontaining an infusion media, and for selectively dispensing infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, there being provided a connector interface forconnecting the reservoir with the infusion pump device, wherein theconnector interface has a cap configured to connect to the reservoir toform a reservoir/cap unit. The method according to such embodimentsincludes providing the reservoir/cap unit with an identifying pattern ofengagement members containing data required to configure the pump forthat particular reservoir/cap unit when the reservoir of thereservoir/cap unit is received in the reservoir receptacle of theinfusion pump device. The method further includes detecting the patternof engagement member using feelers extending into the reservoirreceptacle, each operating an electrical switch on detection ofrespective engagement member to produce electric signals correspondingto the data; and configuring the pump in accordance with the detecteddata.

Optical Detection

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device having a reservoir receptaclefor receiving a reservoir containing an infusion media, and forselectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, where infusionpump device includes at least one optical sensor element. The infusionpump system embodiment further includes a connector interface system forconnecting the reservoir with the infusion pump device. In particularembodiments, the connector interface system has a cap configured toconnect to the reservoir to form a reservoir/cap unit, and where atleast one optically detectable feature is arranged on the cap or thereservoir for detection by the at least one optical sensor element whenthe reservoir of the reservoir/cap unit is received in the reservoirreceptacle of the infusion pump device. In further embodiments, theconnector interface system includes the reservoir to be received withinthe reservoir receptacle of the infusion pump device, where thereservoir contains or is to contain infusion media to be selectivelydispensed from the reservoir when the reservoir is received within thereservoir receptacle. In further embodiments, the connector interfacesystem includes an infusion set coupled to the cap via a tubing forconveying infusion media dispensed from the reservoir.

In further embodiments, the at least one optically detectable featurehas at least one detectable parameter that is associated in a table orother data arrangement with one or more characteristics of the cap,reservoir or infusion pump device.

In particular embodiments, the at least one detectable parameterincludes one or more of: the existence of one or more opticallydetectable features on the cap; the location or pattern of locations ofone or more optically detectable features on the cap; the type ofoptically detectable feature on the cap; the type or content of datastored by the optically detectable feature; or the polarity, wavelength,phase, intensity, direction or orientation of an optical signal emittedor reflected by the optically detectable feature.

In particular embodiments, the detectable parameter of the of at leastone optically detectable feature is associated with one or morecharacteristics that include one or more of: a type or identity of amanufacturer of the reservoir, cap or infusion pump device; a size ofthe reservoir, cap or infusion pump device; a type or concentration ofinfusion media in the reservoir; a volume amount of infusion media inthe reservoir; a date corresponding to a manufacturing date, expirationdate or fill date related to infusion media in the reservoir; a datecorresponding to a manufacturing date or expiration date of thereservoir, cap or infusion pump device; a location corresponding to aplace where the reservoir or infusion media in the reservoir was made,filled, or otherwise processed; a location corresponding to a placewhere the cap or infusion pump device was made, assembled or otherwiseprocessed; a location corresponding to a place where the reservoir,infusion media in the reservoir, cap or infusion pump device isauthorized to be used; a lot number or code associated with a batch inwhich the reservoir, cap, infusion pump device or infusion media wasmade, cleaned, filled or otherwise processed; a serial number; a uniqueID; user identification information for authorized users.

In further embodiments, the infusion pump device includes electronicsfor controlling the selective dispensing of infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, the electronics configured to inhibit dispensing of infusionmedia from the reservoir unless the at least one optically detectablefeature is detected by the at least one optical sensor element.

In further embodiments, the electronics are connected with a memory thatstores the table or other data arrangement, and the electronics areconfigured to control the selective dispensing of infusion media fromthe reservoir when the reservoir is received within the reservoirreceptacle, the selective dispensing being based, at least in part onthe one or more characteristics associated in the table or other dataarrangement with the at least one detectable parameter of the opticallydetectable feature.

In further embodiments, the electronics are configured to recordinformation in the memory, the information corresponding to: (a) atleast one detectable parameter detected by the at least one opticalsensor, or (b) at least one characteristic associated in the table orother data arrangement with at least one detectable parameter detectedby the at least one optical sensor.

In further embodiments, the electronics are further configured to recordlocation information corresponding to a geographic location of theinfusion pump device when the at least one detectable parameter of theoptically detectable feature is detected.

In further embodiments, the electronics are further configured to recordtime information corresponding to a time or date when the at least onedetectable parameter of the optically detectable feature is detected.

In further embodiments, the at least one optically detectable feature isconfigured to alter an optical signal in an optically detectable mannerby altering one or more of the wavelength, direction, phase or othercharacteristic of the optical signal.

In further embodiments, the at least one optically detectable featureincludes: (a) at least one surface of the cap or the reservoir that hasat least one of a material, coating, surface contour or pattern, ribs,grooves, undulations, roughness, abrasions, apertures, detents or anattached article, that inhibits or changes optical reflectivecharacteristics of the at least one surface of the cap; (b) a bar code,matrix code or other optically detectable pattern that representsencoded information; or (c) an adhesive-backed tag that adheres to thecap and that has an outer surface configured to alter an optical signalin an optically detectable manner.

In further embodiments, the at least one optical sensor includes anoptical emitter device configured to emit an optical signal, and anoptical detector device configured to detect an optical signal emittedfrom the optical emitter device and reflected from optically detectablefeature when the reservoir/cap unit is fully received in the reservoirreceptacle of the infusion pump device.

In further embodiments, the infusion pump device has a housing portionin which at least one channel is located, each channel having alongitudinal dimension and arranged in optical alignment with thereservoir receptacle on one end of its longitudinal dimension.

In further embodiments, the optical emitter device and the opticaldetector device of the optical sensor are arranged in optical alignmentwith the at least one channel.

In further embodiments, at least one seal seals the at least one channelto inhibit the passage of fluid through the at least one channel.

In further embodiments, the at least one seal includes (a) an opticallytransparent or partially transparent material that at least partiallyfills the at least one channel along at least part of the longitudinaldimension of the at least one channel, or (b) an optically transparentor partially transparent window material at one end of the at least onechannel.

In further embodiments, (a) the at least one optically detectablefeature includes at least one optically detectable feature provided onat least one predefined location of the cap or the reservoir, foroptical alignment with the optical sensor on the infusion pump devicewhen the reservoir/cap unit is fully received in the reservoirreceptacle of the infusion pump device; (b) the at least one opticallydetectable feature includes a plurality of optically detectable featuresarranged at different respective locations on the cap or on thereservoir; (c) the at least one optically detectable feature is arrangedon the cap or on the reservoir, at a location to be detected by the atleast one optical sensor element when the reservoir/cap unit is fullyreceived in the reservoir receptacle of the infusion pump device, butnot detected by the at least one optical sensor element when thereservoir/cap unit is not fully received in the reservoir receptacle ofthe infusion pump device; (d) the at least one optically detectablefeature includes a plurality of optically detectable features inlocations that allow the optically detectable features to opticallyinteract with the at least one sensor element to provide detectablesignals for detection of axial or rotational motion or position of thecap or the reservoir relative to the reservoir receptacle, when thereservoir/cap unit is received in the reservoir receptacle; or (e) thecap includes at least one thread arranged to engage a correspondingthread or groove in the infusion pump device when the reservoir/cap unitis received in the reservoir receptacle of the infusion pump device,wherein the at least one optically detectable feature is located on theat least one thread.

A connector interface for connecting a reservoir with an infusion pumpdevice according to an embodiment of the present invention includes acap configured to connect to the reservoir to form a reservoir/cap unit,and wherein at least one optically detectable feature is arranged on thecap or the reservoir for detection by at least one optical sensorelement in the infusion pump device when the reservoir of thereservoir/cap unit is received in the reservoir receptacle of theinfusion pump device.

In particular embodiments of such a connector interface, the at leastone detectable parameter includes one or more of: the existence of oneor more optically detectable features on the cap; the location orpattern of locations of one or more optically detectable features on thecap; the type of optically detectable feature on the cap; the type orcontent of data stored by the optically detectable feature; or thepolarity, wavelength, phase, intensity, direction or orientation of anoptical signal emitted or reflected by the optically detectable feature.

In particular embodiments of such a connector interface, the at leastone optically detectable feature includes: (a) at least one surface ofthe cap or the reservoir that has at least one of a material, coating,surface contour or pattern, ribs, grooves, undulations, roughness,abrasions, apertures, detents or an attached article, that inhibits orchanges optical reflective characteristics of the at least one surfaceof the cap; (b) a bar code, matrix code or other optically detectablepattern that represents encoded information; or (c) an adhesive-backedtag that adheres to the cap and that has an outer surface configured toalter an optical signal in an optically detectable manner.

In particular embodiments of such a connector interface, the at leastone optically detectable feature has at least one detectable parameterthat is associated with one or more characteristics of the cap,reservoir or infusion pump device.

In particular embodiments of such a connector interface, the at leastone optically detectable feature has at least one detectable parameterassociated with one or more characteristics that include one or more of:a type or identity of a manufacturer of the reservoir, cap or infusionpump device; a size of the reservoir, cap or infusion pump device; atype or concentration of infusion media in the reservoir; a volumeamount of infusion media in the reservoir; a date corresponding to amanufacturing date, expiration date or fill date related to infusionmedia in the reservoir; a date corresponding to a manufacturing date orexpiration date of the reservoir, cap or infusion pump device; alocation corresponding to a place where the reservoir or infusion mediain the reservoir was made, filled, or otherwise processed; a locationcorresponding to a place where the cap or infusion pump device was made,assembled or otherwise processed; a location corresponding to a placewhere the reservoir, infusion media in the reservoir, cap or infusionpump device is authorized to be used; a lot number or code associatedwith a batch in which the reservoir, cap, infusion pump device orinfusion media was made, cleaned, filled or otherwise processed; aserial number; a unique ID; user identification information forauthorized users.

An infusion pump system according to an embodiment of the presentinvention includes a connector interface according to any of theabove-described embodiments; an infusion pump device having a reservoirreceptacle for receiving the reservoir containing infusion media, andfor selectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, wherein theinfusion pump device includes at least one optical sensor element.

In particular embodiments, the infusion pump device includes electronicsfor controlling the selective dispensing of infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, the electronics being configured to inhibit dispensing ofinfusion media from the reservoir unless the at least one opticallydetectable feature is detected by the at least one optical sensorelement.

In particular embodiments of the infusion pump system, electronics areconnected with a memory that stores a table or other data arrangement,and the electronics are configured to control the selective dispensingof infusion media from the reservoir when the reservoir is receivedwithin the reservoir receptacle, the selective dispensing being based,at least in part on one or more characteristics associated in the tableor other data arrangement with the at least one detectable parameter ofthe optically detectable feature.

In particular embodiments of the infusion pump system, electronics areconfigured to record information in the memory, the informationcorresponding to: (a) at least one detectable parameter detected by theat least one optical sensor, or (b) at least one characteristicassociated in the table or other data arrangement with at least onedetectable parameter detected by the at least one optical sensor.

In particular embodiments of the infusion pump system, the electronicsare further configured to record location information corresponding to ageographic location of the infusion pump device when the at least onedetectable parameter of the optically detectable feature is detected.

In particular embodiments of the infusion pump system, the electronicsare further configured to record time information corresponding to atime or date when the at least one detectable parameter of the opticallydetectable feature is detected.

In particular embodiments of the infusion pump system, the at least oneoptically detectable feature is configured to alter an optical signalincident on the detectable features in an optically detectable manner byaltering one or more of the wavelength, direction, phase or othercharacteristic of the optical signal.

In particular embodiments of the infusion pump system, the at least oneoptical sensor includes an optical emitter device configured to emit anoptical signal, and an optical detector device configured to detect anoptical signal emitted from the optical emitter device and reflectedfrom optically detectable feature when the reservoir/cap unit is fullyreceived in the reservoir receptacle of the infusion pump device.

In particular embodiments of the infusion pump system, the infusion pumpdevice has a housing portion mounting the optical emitter device and theoptical detection device, said housing defining respective channels forthe optical emitter device and the optical detector device.

In particular embodiments of the infusion pump system, at least one sealseals the channels to inhibit the passage of fluid therethrough.

In particular embodiments of the infusion pump system, the at least oneseal includes: (a) an optically transparent or partially transparentmaterial in each channel, or (b) an optically transparent or partiallytransparent window material at one end of the channels, or (c) both (a)and (b).

In particular embodiments of the infusion pump system: (a) the at leastone optically detectable feature includes at least one opticallydetectable feature provided on at least one predefined location of thecap or the reservoir, for optical alignment with the optical sensor onthe infusion pump device when the reservoir/cap unit is fully receivedin the reservoir receptacle of the infusion pump device; (b) the atleast one optically detectable feature includes a plurality of opticallydetectable features arranged at different respective locations on thecap or on the reservoir; (c) the at least one optically detectablefeature is arranged on the cap or on the reservoir, at a location to bedetected by the at least one optical sensor element when thereservoir/cap unit is fully received in the reservoir receptacle of theinfusion pump device, but not detected by the at least one opticalsensor element when the reservoir/cap unit is not fully received in thereservoir receptacle of the infusion pump device; (d) the at least oneoptically detectable feature includes a plurality of opticallydetectable features in locations that allow the optically detectablefeatures to optically interact with the at least one sensor element toprovide detectable signals for detection of axial or rotational motionor position of the cap or the reservoir relative to the reservoirreceptacle, when the reservoir/cap unit is received in the reservoirreceptacle; or (e) the cap includes at least one thread arranged toengage a corresponding thread or groove in the infusion pump device whenthe reservoir/cap unit is received in the reservoir receptacle of theinfusion pump device, wherein the at least one optically detectablefeature is located on the at least one thread.

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device having a reservoir receptaclefor receiving a reservoir containing an infusion media, and forselectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, wherein theinfusion pump device includes an optical emitter device and an opticaldetection device. The infusion pump system further includes a connectorinterface for connecting the reservoir with the infusion pump devicewherein the connector interface has a cap configured to connect to thereservoir to form a reservoir/cap unit, said reservoir/cap unit beingmovable from a first position in which the reservoir is not received inthe reservoir receptacle to a second position in which it is receivedwithin the reservoir receptacle, the reservoir/cap unit further havingan identifying pattern of areas of different reflectivity orrefractivity, disposed on the reservoir/cap unit such that when thereservoir/cap unit is moved from the first position to the secondposition said areas identifying pattern passes between the opticalemitter device and the optical detection device, thereby detecting theidentifying pattern as the reservoir of the reservoir/cap unit isreceived in the reservoir receptacle of the infusion pump device.

In particular embodiments of the infusion pump system, the identifyingpattern of engagement members represents one or more of the followingcharacteristics: a type or identity of a manufacturer of the reservoir,cap or infusion pump device; a size of the reservoir, cap or infusionpump device; a type or concentration of infusion media in the reservoir;a volume amount of infusion media in the reservoir; a date correspondingto a manufacturing date, expiration date or fill date related toinfusion media in the reservoir; a date corresponding to a manufacturingdate or expiration date of the reservoir, cap or infusion pump device; alocation corresponding to a place where the reservoir or infusion mediain the reservoir was made, filled, or otherwise processed; a locationcorresponding to a place where the cap or infusion pump device was made,assembled or otherwise processed; a location corresponding to a placewhere the reservoir, infusion media in the reservoir, cap or infusionpump device is authorized to be used; a lot number or code associatedwith a batch in which the reservoir, cap, infusion pump device orinfusion media was made, cleaned, filled or otherwise processed; aserial number; a unique ID; user identification information forauthorized users; and the infusion pump system contains electronicsincluding a memory that stores a table associating said characteristicswith identifying patterns of engagement members, and the electronics areconfigured to control the selective dispensing of infusion media fromthe reservoir when the reservoir is received within the reservoirreceptacle, the selective dispensing being based, at least in part onthe one or more characteristics associated in the table with thedetected identifying pattern.

An infusion pump device according to an embodiment of the presentinvention has a reservoir receptacle for receiving the reservoircontaining infusion media, the pump device being for selectivelydispensing infusion media from the reservoir when the reservoir isreceived within the reservoir receptacle, wherein the infusion pumpdevice includes: at least one optical sensor element, for detecting anoptically detectable feature on the reservoir, representing its contentsor characteristics of any tubing or infusion set connected thereto; andelectronics connected to the at least one sensor element and configuredto control said selective dispensing at least partially in accordancewith said detected feature.

Further embodiments include a method of configuring an infusion pumpdevice having a reservoir receptacle for receiving a reservoircontaining an infusion media, and for selectively dispensing infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, there being provided a connector interface forconnecting the reservoir with the infusion pump device, wherein theconnector interface has a cap configured to connect to the reservoir toform a reservoir/cap unit and an identifying pattern of areas ofdifferent reflectivity or refractivity, where the method includesproviding the reservoir/cap unit with representing data required toconfigure the pump for that particular reservoir/cap unit when thereservoir of the reservoir/cap unit is received in the reservoirreceptacle of the infusion pump device, detecting the pattern using anoptical emitter device and an optical detection device on the pump; andconfiguring the pump in accordance with the detected data.

Electrical Contact Detection

An infusion pump system according to an embodiment of the presentinvention includes an infusion pump device having a reservoir receptaclefor receiving a reservoir containing an infusion media, and forselectively dispensing infusion media from the reservoir when thereservoir is received within the reservoir receptacle, where infusionpump device includes at least one electrical detection sensor element.The infusion pump system embodiment further includes a connectorinterface system for connecting the reservoir with the infusion pumpdevice. In particular embodiments, the connector interface system has acap configured to connect to the reservoir to form a reservoir/cap unit,and where at least one electrically detectable feature is arranged onthe cap or the reservoir for detection by the at least one sensorelement when the reservoir of the reservoir/cap unit is received in thereservoir receptacle of the infusion pump device. In furtherembodiments, the connector interface system includes the reservoir to bereceived within the reservoir receptacle of the infusion pump device,where the reservoir contains or is to contain infusion media to beselectively dispensed from the reservoir when the reservoir is receivedwithin the reservoir receptacle. In further embodiments, the connectorinterface system includes an infusion set coupled to the cap via atubing for conveying infusion media dispensed from the reservoir.

In further embodiments, the at least one electrically detectable featurehas at least one detectable parameter that is associated with one ormore characteristics of the cap, the reservoir, a cannula, or a tubingconnected between the cap and the cannula.

In particular embodiments, the at least one detectable parameterincludes one or more of: the existence of one or more electricallydetectable features on the cap; the location or pattern of locations ofone or more electrically detectable features on the cap; the type ofelectrically detectable feature on the cap, the electrical resistance ofthe electrically detectable feature, or the electrical impedance of theelectrically detectable feature.

In particular embodiments, the detectable parameter of the of at leastone electrically detectable feature is associated with one or morecharacteristics that include one or more of: a type or identity of amanufacturer of the reservoir or the cap; a size of the reservoir or thecap; a type or concentration of infusion media in the reservoir; avolume amount of infusion media in the reservoir; a date correspondingto a manufacturing date, expiration date, or fill date related toinfusion media in the reservoir; a date corresponding to a manufacturingdate or expiration date of the reservoir or the cap; a locationcorresponding to a place where the reservoir or infusion media in thereservoir was made, filled, or otherwise processed; a locationcorresponding to a place where the cap was made, assembled, or otherwiseprocessed; a location corresponding to a place where the reservoir,infusion media in the reservoir, or the cap is authorized to be used; alot number or code associated with a batch in which the reservoir, thecap, or infusion media was made, cleaned, filled, or otherwiseprocessed; a serial number; a unique ID; user identification informationfor authorized users; a type, length, or size of the cannula; or a type,length, or size of the tubing connected between the cap and the cannula.

In further embodiments, the at least one first electrically conductivecontact member includes a plurality of first electrically conductivecontact members arranged at different respective locations on the cap.

In further embodiments, the at least one first electrically conductivecontact member includes a plurality of first electrically conductivecontact members in locations on the cap that allow one or more of thefirst electrically conductive contact members to come into electricalcontact with the at least one second electrically conductive contactmember to provide detectable signals for detection of axial orrotational motion or position of the cap or the reservoir relative tothe reservoir receptacle, when the reservoir/cap unit is received in thereservoir receptacle.

In further embodiments, the at least one first electrically conductivecontact member is arranged on the cap, at a location to come intoelectrical contact with the at least second electrically conductivecontact member when the reservoir/cap unit is fully received in thereservoir receptacle of the infusion pump device, but not in electricalcontact with the at least one second electrically conductive contactmember when the reservoir/cap unit is not fully received in thereservoir receptacle of the infusion pump device.

In further embodiments, each first electrically conductive contactmember of each electrically detectable feature includes one or more of:(a) an electrically conductive metal member, (b) an electricallyconductive plating, (c) an electrically conductive coating, (d) anelectrically conductive ink, or (e) a smooth strip or pad ofelectrically conductive material.

In further embodiments, one or more of the first electrically conductivecontact members includes a biased conductive portion that is biasedradially outward relative to a housing of the cap.

In further embodiments, the infusion set further includes a cannula, andwherein the at least one electrically detectable feature has at leastone detectable parameter that is associated with one or morecharacteristics of the cannula or the tubing of the infusion set.

In further embodiments, the characteristic of the cannula or the tubingof the infusion set includes a size or length of the cannula, or a sizeor length of the tubing.

In further embodiments, the infusion pump device includes electronicsconnected with an electronic memory, the electronics and electronicmemory are configured to control the selective dispensing of infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, the selective dispensing being based, at least inpart on the one or more characteristics associated with the at least onedetectable parameter in a table or other data arrangement stored in theelectronic memory.

In further embodiments, the infusion pump device includes electronicsconfigured to record information in a memory, the informationcorresponding to one or more of: (a) at least one detectable parameterdetected by the at least one sensor, (b) at least one characteristicassociated with at least one detectable parameter detected by the atleast one sensor, (c) location information corresponding to a geographiclocation of the infusion pump device when the at least one detectableparameter is detected, or (d) time information corresponding to a timeor date when the at least one detectable parameter is detected.

In further embodiments, the infusion pump device includes electronicsfor controlling the selective dispensing of infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, the electronics configured to inhibit dispensing of infusionmedia from the reservoir unless the at least one electrically detectablefeature is detected by the sensor element.

In particular embodiments, the at least one second electricallyconductive contact member is embedded in or affixed to a wall portion ofthe infusion pump device, within the reservoir receptacle.

In particular embodiments, the second electrically conductive contactmember includes a biased portion that is biased radially inward relativeto an axis of the reservoir receptacle, the axis of the reservoirreceptacle being along the axis of the cap or of the reservoir when thereservoir/cap unit is received in the reservoir receptacle.

In particular embodiments, the second electrically conductive contactmember includes a sheet or strip of electrically conductive metalmaterial having two or more extension portions that are bent or foldedpartially to extend outward from the rest of the sheet or strip, thesheet or strip having sufficient flexibility to allow the extensionportions to bend or fold further inward toward the rest of the sheet orstrip when a pressing force is applied to the extension portions, and anatural spring force sufficient to bias the extension portions toward anon-pressed state.

A connector interface for connecting a reservoir containing an infusionmedia with an infusion pump device according to a further embodimentincludes a cap configured to connect to the reservoir to form areservoir/cap unit, where an electrically detectable feature having atleast one first electrical contact is arranged on the cap or thereservoir, for selective connection with a sensor element in theinfusion pump device when the reservoir of the reservoir/cap unit isreceived in a reservoir receptacle of the infusion pump device, whereinthe selective connection conveys data.

In particular embodiments of such a connector interface, the dataincludes one or more of: a type or identity of a manufacturer of thereservoir, cap or infusion pump device; a size of the reservoir, cap orinfusion pump device; a type or concentration of infusion media in thereservoir; a volume amount of infusion media in the reservoir; a datecorresponding to a manufacturing date, expiration date or fill daterelated to infusion media in the reservoir; a date corresponding to amanufacturing date or expiration date of the reservoir, cap or infusionpump device; a location corresponding to a place where the reservoir orinfusion media in the reservoir was made, filled, or otherwiseprocessed; a location corresponding to a place where the cap or infusionpump device was made, assembled or otherwise processed; a locationcorresponding to a place where the reservoir, infusion media in thereservoir, cap or infusion pump device is authorized to be used; a lotnumber or code associated with a batch in which the reservoir, cap,infusion pump device or infusion media was made, cleaned, filled orotherwise processed; a serial number; a unique ID; user identificationinformation for authorized users.

An infusion pump system according to an embodiment of the presentinvention includes a connector interface as described above, and aninfusion pump device having the reservoir receptacle for receiving thereservoir containing the infusion media, and for selectively dispensingthe infusion media from the reservoir when the reservoir is receivedwithin the reservoir receptacle, wherein the infusion pump deviceincludes a plurality of second electrical contacts forming the sensorelement.

A further embodiment of such an infusion pump system includeselectronics coupled to the plurality of electrical contacts of thesensor element to detect when said selective connection has been madeindicating that the reservoir/cap unit is correctly received in thereservoir receptacle.

In a further embodiment of such an infusion pump system, thereservoir/cap unit is movable within the reservoir receptacle from afirst position in which it is correctly received for operation with theinfusion pump device and on partially received position, wherein thesensor element and the detectable feature are configured such that inthe partially received position either none or different ones of saidplurality of contacts connect with the at least one electrical contactand the electronics is configured to indicate that the reservoir/capunit is not correctly received in the reservoir receptacle.

In a further embodiment of any of the above infusion pump systems, atleast one electrical contact is configured in a given pattern such thatwhen the reservoir/cap unit is received in the reservoir receptacle theselective connection indicates data about the cap, the reservoir, orinfusion pump device.

In a further embodiment of any of the above infusion pump systems, theat least one electrical contact is connected to a chip inside the caphaving an internal memory contouring data about the cap or thereservoir, and the sensor element and electronics are configured toreceive the data for communication to the pump.

In a further embodiment of any of the above infusion pump systems, theelectronically detectable feature includes an electrical resistance oran electrical impedance, wherein the sensor element is configured todetect the impedance and determine therefrom data about the cap (4), thereservoir (1), downstream connected structure, or the infusion pumpdevice.

In a further embodiment of any of the above infusion pump systems, theinfusion pump device includes electronics for controlling the selectivedispensing of infusion media from the reservoir when the reservoir isreceived within the reservoir receptacle, the electronics configured toinhibit dispensing of infusion media from the reservoir unless the atleast one electrically detectable feature is detected by the at leastone sensor element.

In a further embodiment of any of the above infusion pump systems, theelectronics are connected with a memory that stores a table or otherdata arrangement, and the electronics are configured to control theselective dispensing of infusion media from the reservoir when thereservoir is received within the reservoir receptacle, the selectivedispensing being based, at least in part on the one or morecharacteristics associated in the table or other data arrangement withthe at least one detectable parameter of the electrically detectablefeature.

In a further embodiment of any of the above infusion pump systems, theelectronics are configured to record information in the memory, wherethe information corresponds to: (a) at least one detectable parameterdetected by the at least one sensor, or (b) at least one characteristicassociated in the table or other data arrangement with at least onedetectable parameter detected by the at least one sensor.

In a further embodiment of any of the above infusion pump systems, theelectronics are further configured to record location informationcorresponding to a geographic location of the infusion pump device whenthe at least one detectable parameter of the electrically detectablefeature is detected.

In a further embodiment of any of the above infusion pump systems, theelectronics are further configured to record time informationcorresponding to a time or date when the at least one detectableparameter of the electrically detectable feature is detected.

In a further embodiment of any of the above infusion pump systems, theat least one first electrical contact arranged on the cap includes oneor more of: (a) an electrically conductive metal member, (b) anelectrically conductive plating, (c) an electrically conductive coating,(d) an electrically conductive ink, (e) a biased conductive portion thatis biased radially outward relative to an axis of the cap or thereservoir, or (f) a smooth, strip or pad configuration.

In a further embodiment of any of the above infusion pump systems, thesecond electrical contacts are attached to, embedded in, molded in,applied onto or affixed to a wall portion of the infusion pump device,within the reservoir receptacle.

In a further embodiment of any of the above infusion pump systems, thesecond electrical contacts: (a) have a smooth, strip or padconfiguration; (b) include a biased portion that is biased radiallyinward relative to an axis of the reservoir receptacle, the axis of thereservoir receptacle being along the axis of the cap or of the reservoirwhen the reservoir/cap unit is received in the reservoir receptacle; or(c) include a sheet or strip of electrically conductive metal materialhaving two or more extension portions that are bent or folded partiallyto extend outward from the rest of the sheet or strip, the sheet orstrip having sufficient flexibility to allow the extension portions tobend or fold further inward toward the rest of the sheet or strip when apressing force is applied to the extension portions, and a naturalspring force sufficient to bias the extension portions toward anon-pressed state.

In a further embodiment of any of the above infusion pump systems: (a)each first electrically conductive contact member of the at least oneelectrically detectable feature is attached to a housing of the cap orto the reservoir; (b) the at least one electrically detectable featureincludes a plurality of first electrically conductive contact membersarranged at different respective locations on the cap or on thereservoir; (c) the at least one electrically detectable feature isarranged on the cap or on the reservoir, at a location to be detected bythe at least one sensor element when the reservoir/cap unit is fullyreceived in the reservoir receptacle of the infusion pump device, butnot detected by the at least one sensor element when the reservoir/capunit is not fully received in the reservoir receptacle of the infusionpump device; (d) the at least one electrically detectable featureincludes a plurality of electrically detectable features in locationsthat allow the electrically detectable features to electrically interactwith the at least one sensor element to provide detectable signals fordetection of axial or rotational motion or position of the cap or thereservoir relative to the reservoir receptacle, when the reservoir/capunit is received in the reservoir receptacle; or (e) the cap includes atleast one thread arranged to engage a corresponding thread or groove inthe infusion pump device when the reservoir/cap unit is received in thereservoir receptacle in the infusion pump device, wherein the at leastone electrically detectable feature is located on the at least onethread.

A further embodiment of any of the above infusion pump systems includeselectronics configured to detect electrical leakage between theplurality of second electrical contact, for example due to moisture or asaline environment, and to ignore said data in the presence of suchleakage.

An infusion pump device according to a further embodiment includes areservoir receptacle for receiving a reservoir containing an infusionmedia, and for selectively dispensing the infusion media from thereservoir when the reservoir is received within the reservoirreceptacle, where the infusion pump device includes a plurality ofsecond electrical contacts forming a sensor element to detect anelectrical contact feature on the reservoir, representing its contentsor characteristics of any tubing or infusion set connected thereto. Theinfusion pump device further includes electronics connected to thesensor element and configured to control said selective dispensing atleast partially in accordance with said detected feature.

Further embodiments include a method of configuring an infusion pumpdevice having a reservoir receptacle for receiving a reservoircontaining an infusion media, and for selectively dispensing infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, there being provided a connector interface forconnecting the reservoir with the infusion pump device, wherein theconnector interface has a cap configured to connect to the reservoir toform a reservoir/cap unit. The method includes providing thereservoir/cap unit with a first contact arranged in the patternrepresenting the data required to configure the pump for that particularreservoir/cap unit when the reservoir of the reservoir/cap unit isreceived in the reservoir receptacle of the infusion pump device;detecting the said pattern using a matrix of resiliently loaded contactson the reservoir receptacle, when the reservoir/cap unit is received inthe reservoir receptacle and deriving the data therefrom; andconfiguring the pump in accordance with the derived data.

Further embodiments include a method of configuring an infusion pumpdevice having a reservoir receptacle for receiving a reservoircontaining an infusion media, and for selectively dispensing infusionmedia from the reservoir when the reservoir is received within thereservoir receptacle, there being provided a connector interface forconnecting the reservoir with the infusion pump device, wherein theconnector interface has a cap configured to connect to the reservoir toform a reservoir/cap unit, where the method includes providing thereservoir/cap unit with a chip and contacts connected to the chip on asurface facing the infusion pump device. In such embodiments, the chipcontains data required to configure the pump for that particularreservoir/cap unit when the reservoir of the reservoir/cap unit isreceived in the reservoir receptacle of the infusion pump device. Themethod in such embodiments includes connecting the contacts tocorresponding contacts on the infusion pump device as the reservoir/capunit is received in the reservoir receptacle; reading said data from thechip into the infusion pump device; and configuring the pump device inaccordance with the read data.

Reservoir/Cap/Infusion Set Units (Twist and Lock)

A reservoir unit system for an infusion pump device according to anembodiment of the present invention includes a reservoir containerhaving a neck portion and an interior volume for containing an infusionmedium, where the neck portion has a port opening through which infusionmedia may be received into the interior volume of the reservoir, andwhere the neck portion has a flow channel with a first opening to theinterior volume of the reservoir container and a second opening forconnection in flow communication with a tubing. This reservoir unitsystem embodiment also includes a cap having a cap body supported in theneck portion of the reservoir for rotation about an axis between a firstrotary position and a second rotary position, where the cap body has afirst channel opening to the interior volume of the reservoir, and asecond channel having first and second ends, the first end in fluid flowcommunication with the first channel in the cap body, and the secondend.

This reservoir unit system embodiment may further include a transferguard that is removably connected to the reservoir neck portion forselective rotation about the axis relative to the reservoir neck portionbetween a first transfer guard rotary position and a second transferguard rotary position. The transfer guard is operatively engaged withthe cap body for rotating the cap body from the first rotary position tothe second rotary position as the transfer guard is selectively rotatedfrom the first transfer guard rotary position to the second transferguard rotary position. The second end of the second channel in the capbody is in fluid flow communication with the first opening of the flowchannel in the neck portion when the cap body is in the first rotaryposition, and wherein the second end of the second channel in the capbody is out of fluid flow communication with the first opening of theflow channel in the neck portion when the cap body is in the secondrotary position.

In particular embodiments: (a) the cap body has at least one extensionconfigured to receive a manual force to rotate the cap body about theaxis relative to the reservoir container, and the transfer guard isoperatively engaged with the at least one extension of the cap body forrotating the cap body from the first rotary position to the secondrotary position as the transfer guard is selectively rotated from thefirst transfer guard rotary position to the second transfer guard rotaryposition, where the transfer guard includes a transfer guard body havinga first end for receiving the neck portion of the reservoir container,the transfer guard body having an opening through which the at least oneextension of the cap body is received and an engagement surface forengaging the at least one extension of the cap body when the reservoircontainer is received in the first end of the transfer guard body, wherethe transfer guard body has a second end for receiving a portion of asupply container, the transfer guard configured to connect the supplycontainer in fluid flow communication with the reservoir container whenthe reservoir container is received in the first end of the transferguard body and the supply container is received in the second end of thetransfer guard body; (b) the cap body has at least one extensionconfigured to receive a manual force to rotate the cap body about theaxis relative to the reservoir container, and the reservoir neck portionhas at least one extension arranged in a position to align with the atleast one extension of the cap body when the cap body is in the firstrotary position, and arranged in a position out of alignment with the atleast one extension of the cap body when the cap body is in the secondrotary position; or (c) the cap body has an extension that has alongitudinal dimension extending outward relative to the axis, thereservoir neck portion has an extension that has a longitudinaldimension extending outward relative to the axis, where the longitudinaldimension of the extension of the cap body is directed in the samedirection as the longitudinal dimension of the extension of thereservoir neck portion when the cap body is in the first rotaryposition, and where the longitudinal dimension of the extension of thecap body is directed in a different direction than the longitudinaldimension of the extension of the reservoir neck portion when the capbody is in the second rotary position.

In further embodiments, the cap includes a pierceable septum in thefirst channel of the cap body.

In further embodiments, the cap includes at least one detectable elementthat can be detected by a sensor on an infusion pump device, where theat least one detectable element is located on the extension.

In particular embodiments, the at least one detectable element includesat least one of a magnetically detectable element, an inductivelydetectable element, an optically detectable element, a mechanicallydetectable element, an electrically detectable electrical contactelement, a radio frequency (RF) detectable element; or a radio frequency(RF) detectable element that includes an RFID tag. The detail andfunction of the detectable element and associated sensors is asdescribed above.

Reservoir/Cap/Infusion Set Units (Spring Loaded Plunger)

A reservoir unit system for an infusion pump device according to anotherembodiment of the present invention includes a reservoir containerhaving a neck portion and an interior volume for containing an infusionmedium, where the neck portion has a port opening through which infusionmedia may be received into the interior volume of the reservoircontainer, and where the neck portion has a flow channel with a firstopening to the interior volume of the reservoir container and a secondopening for connection in flow communication with a tubing. Thisreservoir unit system embodiment further includes a cap structure havinga moveable plunger body supported in the neck portion of the reservoirfor linear motion along an axial direction of the reservoir container,between a first position and a second position. The plunger body has atleast one passage for fluid flow communication through the plunger bodybetween the port opening and the interior volume of the reservoircontainer. The cap structure has a bias member providing a bias forcethat biases the moveable plunger body toward the first position.

This reservoir unit system embodiment further includes a transfer guardhaving a first end that is removably connectable to the neck portion ofthe reservoir container, where the transfer guard includes an engagementportion arranged to engage the moveable plunger body and hold theplunger body in the second position against the bias force of the biasmember when the transfer guard is connected to the neck portion of thereservoir container. The engagement portion is arranged to disengage themoveable plunger body to allow the moveable plunger body to move fromthe second position to the first position under the bias force of thebias member when the transfer guard is removed from the neck portion ofthe reservoir container.

The moveable plunger body has an outer surface arranged relative to thefirst opening of the flow channel in the neck portion of the reservoircontainer such that: (a) when the moveable plunger body is in the firstposition, the outer surface of the plunger body is aligned with thefirst opening of the flow channel to block fluid flow communicationbetween the flow channel and the interior volume of the reservoircontainer, and (b) when the moveable plunger body is in the secondposition, the outer surface of the plunger body is sufficientlyseparated from the first opening of the flow channel to allow fluid flowcommunication between the flow channel and the interior volume of thereservoir container.

In particular embodiments, the engagement portion includes a hollowneedle that provides a fluid flow communication path between first andsecond ends of the hollow needle.

In particular embodiments, the transfer guard includes a second endconfigured to interface with a supply container, the second end of thehollow needle being arranged in fluid flow communication with aninterior volume of the supply container when the second end of thetransfer guard interfaces with the supply container.

In particular embodiments, a portion of the hollow needle extendsthrough the port opening with the first end of the hollow needlearranged in fluid flow communication with the interior volume of thereservoir container when the first end of the transfer guard isconnected with the neck portion of the reservoir container.

In further embodiments, the neck portion of the reservoir containerincludes one or more first stop surfaces and one or more second stopsurfaces arranged to hold the moveable plunger within the interiorvolume of the neck portion, yet allow movement of the moveable plungerbetween the first and second positions.

In particular embodiments, the one or more first stop surfaces include aring-shaped projection arranged at or adjacent a section of the neckportion where an interior volume of the neck portion opens into the restof the interior volume of the reservoir container, and the one or moresecond stop surfaces include a ring-shaped projection arranged at oradjacent the port opening of the reservoir container.

In particular embodiments, one or more of the first and second stopsurfaces are (a) formed integral with the neck portion of the reservoircontainer as a unitary molded structure, or (b) formed as separateelements that are fixed to the neck portion of the reservoir container.

In further embodiments, a pierceable septum is provided within the neckportion of the reservoir container, adjacent the port opening of thereservoir container, the pierceable septum arranged to be pierced by thesecond end of the hollow needle when the second end of the transferguard is interfaced with the neck portion, the pierceable septumarranged to seal the port opening of the reservoir container when thesecond end of the transfer guard is not interfaced with the neck portionof the reservoir container.

In further embodiments, the cap structure includes at least onedetectable element that can be detected by a sensor on an infusion pumpdevice, where the at least one detectable element is located on themoveable plunger or the bias member.

In particular embodiments, the at least one detectable element includesat least one of a magnetically detectable element, an inductivelydetectable element, an optically detectable element, a mechanicallydetectable element, an electrically detectable electrical contactelement, a radio frequency (RF) detectable element; or a radio frequency(RF) detectable element that includes an RFID tag. The detail andfunction of the detectable element and associated sensor is the same asset out in respect of the earlier described embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partially exploded, perspective view of an infusion pumpsystem including an infusion pump device, reservoir, infusion set andconnection interface apparatus according to an embodiment of the presentinvention.

FIG. 2 is an enlarged, side, cross-section view of a cap of a reservoirconnection interface apparatus according to an embodiment of the presentinvention.

FIG. 3 is a partial side, cross-section view of the cap of theembodiment in FIG. 2, connected with a reservoir.

FIGS. 4A and 4B are schematic diagrams, each showing a top-downrepresentation of cap, sensors and detectable elements employed by aconnection interface apparatus according to embodiments of the presentinvention.

FIGS. 4C and 4D are perspective views of caps according to embodimentsof the present invention.

FIG. 4E is a schematic cross-sectional diagram of a portion of aninfusion pump device on which a cap of FIG. 4C or 4D is installed.

FIG. 4F is a chart plotting an example of a magnetic flux density as afunction of an engagement angle of a cap in an infusion pump device ofFIG. 4E.

FIG. 4G are schematic diagrams of magnet shapes and magnetic fielddirections.

FIGS. 4H and 4I are schematic cross-sectional diagrams of a portion ofan infusion pump device on which a cap of FIG. 4C or 4D is installed,with respectively different directed magnetic fields.

FIGS. 4J and 4K are schematic perspective views of a circumferentiallymagnetized magnet and arrangement, according to an embodiment of thepresent invention.

FIGS. 4L and 4M are a schematic perspective view of a radiallymagnetized magnet and a schematic cross section view of an arrangementof that magnet within a portion of an infusion pump device, according toan embodiment of the present invention.

FIGS. 4N and 4O are a schematic perspective view of an axiallymagnetized magnet and a schematic cross section view of an arrangementof that magnet within a portion of an infusion pump device, according toan embodiment of the present invention.

FIG. 4P is a graph representing an example of a linear response outputof a linear Hall effect sensor.

FIG. 4Q is a graph representing an example of an output of a digitalHall effect switch sensor with hysteresis.

FIGS. 4R and 4S are graphs, each representing an example of an output ofan AMR sensor upon relative movement of an adjacent magnet.

FIGS. 4Ta-4Td are graphs, each representing a magnet angle relative toan AMR sensor.

FIGS. 4U-4V are graphs, representing sensor outputs and magnetic fieldangles according to embodiments of the present invention.

FIG. 5 is a schematic diagram showing a generalized representation of anelectronic circuit employed by a connection interface apparatusaccording to embodiments of the present invention.

FIG. 6 is a flow diagram of a process performed by the electroniccircuit of FIG. 5 according to an embodiment of the present invention.

FIG. 7 is a perspective view of an infusion pump system including abase/reservoir/cap unit outside of an infusion pump device, according toan embodiment of the present invention.

FIG. 8 is an enlarged, side, cross-section view of a portion of aninfusion pump system of the embodiment of FIG. 7, with thebase/reservoir/cap unit located inside the infusion pump device.

FIG. 9 is a schematic diagram showing a generalized representation of anelectronic circuit for embodiments of an infusion pump system of FIGS. 7and 8.

FIG. 10 is an enlarged, side, cross-section view of a portion of anembodiment of an infusion pump device of an infusion pump system ofFIGS. 7 and 8.

FIG. 11 is an enlarged, side, cross-section view of a portion of anembodiment of a cap located in an infusion pump device of an infusionpump system of FIGS. 7 and 8.

FIG. 12 is an enlarged, side, cross-section view of a portion of anembodiment of a cap located outside another example of an infusion pumpdevice of an infusion pump system of FIGS. 7 and 8.

FIG. 13 is an enlarged, side, cross-section view of a portion of anembodiment of a cap located in an infusion pump device of FIG. 12.

FIG. 14 is an enlarged, side, cross-section view of a portion of anotherembodiment of a cap located in an infusion pump device of FIG. 12.

FIG. 15 is an enlarged, side, cross-section view of an embodiment of alinkage structure in an infusion pump device of FIGS. 12-14.

FIG. 16 is a side, cross-section view of a portion of an infusion pumpsystem, with a base/reservoir/cap unit located inside a infusion pumpdevice, according to an embodiment of the present invention.

FIG. 17 is a side, plan cut-away view of a portion of an infusion pumpdevice in which a base/reservoir/cap unit is installed, according to anembodiment of the present invention.

FIG. 18 is an enlarged side, plan cut-away view of the portion of theinfusion pump device shown in FIG. 17, but without a base/reservoir/capunit.

FIG. 19 is a top view of an infusion pump device housing portionaccording to an embodiment of the present invention.

FIG. 20 is a perspective view of the infusion pump device housingportion of the embodiment of FIG. 19.

FIG. 21 is a perspective view of portions of an infusion pump systemincluding a cap outside of a portion of an infusion pump device,according to an embodiment of the present invention.

FIG. 22 is a perspective view of portions of an infusion pump systemincluding a cap outside of a portion of an infusion pump device,according to another embodiment of the present invention.

FIG. 23A is an enlarged perspective view of an embodiment of anelectrical contact member on a cap of FIG. 21.

FIG. 23B is an enlarged perspective view of another embodiment of anelectrical contact member for a cap of FIG. 21 or 22.

FIG. 23C is an enlarged perspective view of another embodiment of anelectrical contact member for a cap of FIG. 21 or 22.

FIG. 23D is an enlarged, side, cross-section view of another embodimentof an electrical contact member for a cap or an infusion pump device ofFIG. 21 or 22.

FIG. 23E is an enlarged, side, cross-section view of another embodimentof an electrical contact member for a cap or an infusion pump device ofFIG. 21 or 22.

FIG. 24 is a perspective view of an infusion pump system including a capoutside of the infusion pump device, according to another embodiment ofthe present invention.

FIG. 25 is a schematic diagram representing a portion of the infusionpump system of FIG. 24, with the cap on the infusion pump device.

FIG. 26 is a schematic diagram of a detection circuit according to anembodiment of the present invention.

FIG. 27 is a schematic diagram of a detection circuit according toanother embodiment of the present invention.

FIG. 28A is a perspective view of a cap and reservoir connected with atransfer guard and FIG. 28B is a perspective view of the same cap andreservoir with the transfer guard in the state of being removed,according to an embodiment of the present invention.

FIGS. 29A and 29B are a perspective view and a cut-away side view of thecap and reservoir of FIG. 28A in a first or fill state.

FIGS. 30A and 30B are a perspective view and a cut-away side view of thecap and reservoir of FIG. 28A in a second or delivery state.

FIG. 31 is a partial exploded view of the cap, reservoir and transferguard of FIG. 28A, with a supply container.

FIG. 32 is an enlarged, partial cross-section view of a portion of atransfer guard engaged with a reservoir having a cap according to afurther embodiment of the present invention.

FIG. 33 is an enlarged, partial cross-section view of a portion of thereservoir and cap according to the embodiment of FIG. 32, but with thetransfer guard removed.

FIG. 34 is an enlarged, partial exploded view of the cap, reservoir andtransfer guard of FIG. 32.

FIG. 35 is an enlarged, partial cut-away view of a cap and reservoirreceptacle according to a further embodiment of the present invention.

FIG. 36 is a partial perspective view of a cap and reservoir receptacleaccording to a further embodiment of the present invention.

FIG. 37 is a partial perspective view of the cap and reservoirreceptacle of the embodiment of FIG. 18, but with a user's fingerpressing a button portion.

FIG. 38 is an enlarged, perspective view of a cap that may be employedwith the embodiment of FIGS. 36 and 37.

FIG. 39 is a schematic diagram of a button configuration according toembodiments of the present invention.

FIG. 40 is a partial perspective view of a portion of a cap and aportion of a reservoir receptacle according to a further embodiment ofthe present invention.

FIG. 41 is a partial perspective view of the portion of the cap and theportion of the reservoir receptacle of the embodiment of FIG. 40, butwith a button portion in the pressed state.

FIG. 42 is a partial perspective view of a portion of a cap and aportion of a reservoir receptacle according to a further embodiment ofthe present invention.

FIG. 43 is a partial perspective view of a cap and a portion of areservoir receptacle of an infusion pump device according to a furtherembodiment of the present invention.

FIG. 44 is a partial perspective view of the cap and reservoirreceptacle of the embodiment of FIG. 43, but in a locked or latchedstate.

FIG. 45 is a partial perspective view of the cap and reservoirreceptacle of the embodiment of FIG. 43, but in an unlocked or unlatchedstate.

FIG. 46 is a partial cut-away, perspective view of the cap and reservoirreceptacle of the embodiment of FIG. 43, showing button members.

FIG. 47 is a partial perspective view of a portion of the reservoirreceptacle of the embodiment of FIGS. 43-46.

FIGS. 48 and 49 are partial perspective views of a cap and a portion ofa reservoir receptacle of an infusion pump device according to a furtherembodiment of the present invention.

FIGS. 50 and 51 are partial perspective views of the cap and reservoirreceptacle of the embodiment of FIGS. 48 and 49, but in a locked orlatched state.

FIG. 52 is a top view of a cap of a reservoir connection interfaceapparatus according to an embodiment of the present invention.

FIG. 53 is a partial perspective view of a portion of a reservoirreceptacle of an infusion pump device that operates with a cap of FIG.52.

FIG. 54 is an enlarged, partial top view of an embodiment of a cap thatoperates with an infusion pump device of FIG. 53.

FIG. 55 is a partial side, cross-section view of a portion of areservoir receptacle of an infusion pump device containing abase/reservoir/cap unit having a cap-to-infusion pump device connectioninterface according to an embodiment of the present invention.

FIG. 56 is a partial side, cross-section view of a portion of areservoir receptacle of an infusion pump device containing abase/reservoir/cap unit having a cap-to-infusion pump device connectioninterface according to another embodiment of the present invention.

FIG. 57 is an enlarged, partial perspective view of a portion of areservoir receptacle of an infusion pump device and a cap having acap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 58 is an enlarged, side, cross-section view of an upper ring memberhaving a portion of a connection interface of FIG. 57.

FIG. 59 is an enlarged, partial perspective view of a portion of areservoir receptacle of an infusion pump device and a cap having acap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 60 is an enlarged, top view of rotary ring member of a connectioninterface of FIG. 59.

FIG. 61 is an enlarged, partial side, cross-section view of a portion ofa reservoir receptacle of an infusion pump device having acap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 62 is an enlarged, partial side, cross-section view of a portion ofa reservoir receptacle of an infusion pump device having thecap-to-infusion pump device connection interface of FIG. 61, but in asecond rotary position.

FIG. 63 is an enlarged, top view of rotary ring member of a connectioninterface of FIGS. 61 and 62.

FIG. 64 is an enlarged, partial, side, cross-section view of a portionof a reservoir receptacle of an infusion pump device and a cap having acap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 65 is an enlarged, side, cross-section view of a portion of the capof FIG. 64 connected, through the connection interface, to a portion ofthe infusion pump device of FIG. 64.

FIG. 66 is an enlarged, bottom view of the cap of FIGS. 64 and 65.

FIG. 67 is an enlarged, partial exploded, partial perspective view of aportion of a reservoir receptacle of an infusion pump device and a caphaving a cap-to-infusion pump device connection interface according toanother embodiment of the present invention.

FIG. 68 is an enlarged, partial perspective view of a portion of areservoir receptacle of an infusion pump device of FIG. 67, with thering member of the connection interface within the reservoir receptacle.

FIG. 69 is an enlarged, partial side, cross-section view of a cap and aportion of a reservoir receptacle of an infusion pump device having acap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 70 is an enlarged, partial side, cross-section view of a cap withina portion of a reservoir receptacle of an infusion pump device of FIG.69.

FIG. 71 is an enlarged, exploded perspective view of a portion of areservoir receptacle of an infusion pump device of FIG. 69.

FIG. 72 is an enlarged, partial perspective view of a cap and a portionof a reservoir receptacle of an infusion pump device having acap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 73 is an enlarged, perspective view of an upper ring member havinga cap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 74 is an enlarged, partial, side, cross-section view of a portionof a reservoir receptacle of an infusion pump device and a cap having acap-to-infusion pump device connection interface according to anotherembodiment of the present invention.

FIG. 75 is an enlarged, side, cross-section view of a cap within aportion of a reservoir receptacle of FIG. 74.

FIGS. 76 and 77 are partial perspective views of a base/reservoir/capunit or reservoir within a reservoir receptacle according to variousembodiments of the present invention.

FIG. 78 is a top view of an infusion pump device having a side-entryreservoir receptacle according to an embodiment of the presentinvention.

FIG. 79 is a partial perspective view of the infusion pump device ofFIG. 78, with a portion of a cap extending through an opening in theinfusion pump device housing.

FIG. 80 is a top view of an infusion pump device having a side-entryreservoir receptacle according to another embodiment of the presentinvention.

FIG. 81 is a partial perspective view of the infusion pump device ofFIG. 80, with a portion of a cap extending through an opening in theinfusion pump device housing.

FIG. 82 is a partial perspective view of a cap of a reservoir connectioninterface apparatus according to an embodiment of the present invention.

FIG. 83 is a partial perspective view of an upper ring member of areservoir receptacle of an infusion pump device according to anembodiment of the present invention.

FIG. 84 is an enlarged, partial exploded, partial perspective view of aportion of a reservoir and a cap having a cap-to-reservoir connectioninterface according to another embodiment of the present invention.

FIG. 85 is an enlarged, partial perspective view of a cap connected to aportion of a reservoir of FIG. 84.

FIG. 86 is an enlarged, partial, side, cross-section view of a portionof a reservoir of FIGS. 84 and 85.

FIG. 87 is an enlarged, cross-section view of transfer guard connectedwith a cap, and an adjacent portion of a vial according to an embodimentof the present invention.

FIG. 88 is an enlarged, cross-section view of transfer guard connectedwith a cap with a vial of FIG. 87.

DETAILED DESCRIPTION

In the following description, reference is made to the accompanyingdrawings which form a part of this application and which illustrateseveral embodiments of the present invention. It is understood thatother embodiments may be utilized and structural and operational changesmay be made without departing from the scope of the present invention.

In various drawings, like numerals are used to represent the sameelements or similar elements that may perform or operate in a similarmanner. The use of the term “and/or” herein is intended to represent an“inclusive OR.” In addition, the user of the term “or” herein isintended to represent an “inclusive OR” except where such a meaningwould not make sense.

Embodiments of the present invention relate to connection interfaces forsyringes and reservoirs. Particular embodiments relate to connectioninterfaces for interfacing a syringe or reservoir (such as reservoir 1described below) to an infusion pump device (such as infusion pumpdevice 30 described below), an infusion set tubing (such as tubing 52described below), or both. Further embodiments relate to infusion pumpsystems and infusion set systems that include such connectioninterfaces, and to methods of making and using such connectioninterfaces and systems.

An infusion pump system according to an embodiment of the presentinvention is shown, in a partially exploded, perspective view, inFIG. 1. The infusion pump system in FIG. 1 includes a reservoir 1, aninfusion pump device 30, a connection interface 40, and an infusion set50. The infusion set system in FIG. 1 includes the infusion set 50 andthe connection interface 40. Further system embodiments may include oneor more, but not all of the above-noted components, and/or additionalcomponents not shown in FIG. 1.

As described below, the reservoir 1 is configured to be received withina receptacle 32 of the infusion pump device 30 and to interface with adrive device (not shown) located within the infusion pump device, forselectively driving infusion media from the reservoir in a controlledmanner. The reservoir 1 is also configured to be connected in fluid flowcommunication with the infusion set 50, for providing a flow path forinfusion media from the reservoir to a user. In particular embodimentsdescribed herein, the connection interface 40 is configured to connectand interface the reservoir 1 with the infusion set 50 and with theinfusion pump device 30, using releasable couplers.

The infusion set 50 includes a tubing 52 and a needle or cannula housing54. In particular embodiments, the tubing 52 may be generally flexibleand bendable, but may also include or be encased in a protective sheathmade of a suitably rigid material or is otherwise configured to inhibitkinking of the tubing 52. The needle or cannula housing 54 is configuredto be secured to a user, such as, but not limited to, adhering thehousing 54 to a user's skin, at a desired infusion location on the user.The housing 54 may include adhesive material on its base, or othersuitable material or structure, for securing the housing 54 to theuser's skin. The housing 54 contains and supports a hollow needle orcannula 56 that is in fluid flow communication with the tubing 52 andthat is configured to extend (or to be extended) out from the base andinto the user's skin, when the housing 54 is secured to the user's skin.When extended into a user's skin, the hollow needle or cannula 56 canconvey infusion media from the tubing 52, into the user. Examples ofinfusion sets that may be employed as an infusion set 50 include, butare not limited to a Quick-set® infusion set, a Silhouette® infusionset, a Sure-T® infusion set, a Mio® infusion set, or the like. However,other embodiments of the present invention may include or operate withother suitable infusion set configurations.

Examples of infusion pump devices that may be employed as an infusionpump device 30 include, but are not limited to a Paradigm® infusionpump, a Revel™ infusion pump, a MiniMed® 530G infusion pump, MiniMed640G, or the like. Other examples include those described in U.S. Pat.Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122, each ofwhich is incorporated by reference herein, in its entirety. However,other embodiments of the present invention may include or operate withother suitable infusion pump devices. The infusion pump device 30includes a drive motor or other drive device with drive linkage (notshown) arranged to engage corresponding drive linkage 1′ on a piston inthe reservoir 1, when the reservoir 1 is properly received within thereservoir receptacle 32. In particular embodiments, the drive linkage 1′corresponds to an “engagement side 128” described in U.S. Pat. No.8,167,846 titled “Reservoir Filling Systems And Methods”, which isincorporated herein by reference, in its entirety. In other embodiments,other suitable drive linkage structure is employed as the drive linkage1′ for operatively coupling the piston in the reservoir 1 to the drivedevice in the infusion pump device 30, when the reservoir 1 is receivedin the reservoir receptacle of the infusion pump device 30.

The drive device operates to selectively move the piston within thesyringe or reservoir, to drive fluidic media from the reservoir and tothe user. The infusion pump device 30 includes control electronicsconnected to the drive device for controlling the drive device toselectively drive the piston and dispense fluid from the reservoir andinto the tubing 52 of the infusion set 50. In particular embodiments,the control electronics are programmable to deliver fluid from thereservoir continuously or at one or more predefined intervals over time,in accordance with one or more programmed delivery routines. The controlelectronics may be further configured to operate one or more displaydevices and user input devices on or associated with the infusion pumpdevice. The control electronics may include or be connected with theelectronics 60 described below with reference to FIG. 5.

1. Connection Interface Structure and Operation

In the embodiment of FIG. 1, the connection interface 40 includes a base2 and a connection cap 4. In other embodiments, the base 2 is omitted oris formed as part of (unitary with or fixed to) the reservoir 1 or thecap 4. In the embodiment of FIG. 1, the base 2 is a separate elementthat is fixedly attached to the reservoir 1 by securing it around aswage 3 of the reservoir 1, during (or after) manufacturing of thereservoir 1. For example, the base 2 may include one or more slots 2 aand may be made of a rigid, but sufficiently malleable material that canbe crimped over the swage 3 to secure the base to the reservoir 1. Inparticular embodiments, the base 2 is fixedly connected to the reservoir1 in a manner that inhibits rotation or motion of the base 2 relative tothe reservoir 1. Other embodiments may include other suitable structureor materials for securing the base 2 to the swage 3. In otherembodiments of the present invention, the base 2 is configured to beattachable to (and removable from) the reservoir, so that the connectorinterface could be used with reservoirs, cartridges or syringes thatwere not initially manufactured with the base attached.

The base 2, swage 3 and the cap 4 may be made of any one or moresuitable materials having sufficient rigidity and strength to operate asdescribed herein, including, but not limited to plastic, metal, ceramic,composite or other suitable material. In one example, the base 2 is madeof a metal material that can be crimped over the crimp seal swage 3, thebase is made of a metal foil material that can be formed over a port ofthe reservoir 1, and the base 2 is made of a plastic material (such as,but not limited to a plastic material that is molded into a singleunitary structure having the shape of the cap 4). In particularembodiments, the cap 4 is made of a molded plastic material.

The cap 4 of the connector interface 40 connects, in fluid flowcommunication, with the tubing 52 of the infusion set 50. An exampleembodiment of the cap 4 is shown in FIGS. 2 and 3. A cross-section viewof the cap 4 is shown in FIG. 2, with the cap separated from areservoir. A cross-section view of the cap 4 is shown in FIG. 3, withthe cap attached to a neck portion of a reservoir 1. In the embodimentof FIGS. 2 and 3, the cap 4 includes a housing 5 having an open end thatopens into an interior volume of the cap housing 5. The housing 5 alsoincludes a tubing port 6 that connects with the tubing 52 of theinfusion set 50 in any suitable manner, including, but not limited to afriction fit, clamp, adhesive, combinations thereof, or the like. Inparticular embodiments, the cap 4 is connected with the tubing 52 duringmanufacture or assembly of the cap 4, before the cap 4 is made availableto the user. In other embodiments, the cap 4 has a port configured to beconnected to the tubing 52 after manufacture of the cap, for example, bythe user, medical technician or other authorized person. The cap 4 alsoincludes a needle 9 located internal to the cap housing and provided influid flow communication with the tubing port 6. In particularembodiments, the cap 4 includes one or more vent openings 24 thatprovide an air passage from the environment outside of the cap 4, to theinterior volume of the cap body 5. As described herein, the one or morevent openings 24 allow pressure equalization between the exteriorenvironment and the interior environment of the cap body 5.

The cap 4 portion of the connector interface 40 removably attaches tothe base 2 (and, thus, to the reservoir 1) with a first releasablecoupler. In embodiments in which the base 2 is omitted, the firstreleasable coupler removably attaches the cap 4 directly to thereservoir 1. In addition, the cap 4 removably attaches to the infusionpump device 30 with a second releasable coupler. In particularembodiments, the first releasable coupler includes any suitablestructure that allows selective coupling and decoupling of the cap withthe base 2, while the second releasable coupler includes a similar ordifferent structure that allows selective coupling and decoupling of thecap with the infusion pump device 30. Example embodiments of firstreleasable couplers for coupling a cap to a base of a connectioninterface, and second releasable coupler for coupling a cap to aninfusion pump device are described in U.S. Pat. No. 6,585,695, which isincorporated herein, in its entirety.

In one embodiment, the first releasable coupler includes one or moreprotrusions or detents provided on one of the base 2 or the cap 4, andcorresponding openings in the other of the base 2 or the cap 4, forreceiving the protrusions or detents. An example embodiment of a firstreleasable coupler is described with reference to the cap 4, base 2 andreservoir 1 shown in FIGS. 2 and 3. In other embodiments, other suitablecoupler structures for releasably coupling or permanently coupling thecap 4, base 2 and reservoir 1 (or for releasably coupling or permanentlycoupling the cap 4 directly to the reservoir 1) are employed.

In the embodiment of FIGS. 2 and 3, the cap 4 portion of the connectorinterface 40 is removably attachable to the base 2 with a firstreleasable coupler that includes detents on the base 2 and detentopenings disposed in a housing portion of the cap 4. Two detents 8 areprovided on an outer surface of the base 2 and are spaced 180 degreesapart, but only one detent 8 is in view in FIG. 1. The detents 8 aresized to fit in two detent openings 10 in the cap 4. As with the pair ofdetents 8, the detent openings 10 are radially spaced apart by 180degrees.

The base 2 is connected to the reservoir 1, to form an integrated unitwith the reservoir 1. The integrated unit of the reservoir 1 and thebase 2 is, in turn, connected to the cap 4. For example, in theembodiment of FIG. 1, the integrated base/reservoir unit is connected tothe cap 4 by inserting the base 2 into an open, lower end of the cap 4.The detents 8 slide into and mate with correspondingly shaped andlongitudinally open entry slots 15 within the interior housing walls ofthe cap 4. When the base 2 is fully inserted in the cap housing 5, theleading edges of the detents 8 abut an annular stop shoulder 16 formedwithin the cap 4. After the detents 8 are in this position, the base 2is rotated within the cap 4 toward a locked position. Referring to FIG.2, this rotation displaces the detents 8 in a rotational direction forengagement with cam surfaces 17 within the cap 4. The rotational forceon the detents 8 over the cam surfaces 17 provides a compression forceon the detents 8. Continued rotation of the base 2 displaces the detents8 past the cam surfaces 17 and into alignment with the detent openings10. The detents 8 enter the detent openings 10 with a snap-action. Thus,the detents 8 are effectively locked within the detent openings 10 toinhibit longitudinal separation of the base 2 from the cap 4.Accordingly, the base/reservoir unit is connected with the cap 4 to forman integrated base/reservoir/cap unit. (In embodiments in which the base2 is omitted or incorporated in the reservoir or cap, the referencesmade herein to a base/reservoir/cap unit shall be read to meanreservoir/cap unit.)

In particular embodiments, the internal needle 9 of the cap 4 isdisposed so that when the base/reservoir unit is fully inserted in thecap 4, the needle pierces the septum (not shown) of the reservoir 1. Insuch embodiments, the insertion motion and force of the base/reservoirunit into the open end of the cap 4, to the point where the detents 8abut the annular stop shoulder 16, causes the needle 9 to pierce thereservoir septum, permitting fluid in the reservoir to flow into theneedle 9 and the tubing 52 of the infusion set 50.

To disconnect the base 2 from the cap 4, the base 2 is manually rotatedrelative to the cap 4 in a reverse direction relative to the directionfor connection. This causes the detents 8 to move along the cam surfaces17 into re-alignment with the entry slots 15. When the detents 8 aremoved to re-aligned with the entry slots 15, the cap 4 and base 2 can beseparated with minimal longitudinal force.

As shown in FIG. 1, the cap 4 is connects to the base 2 and thereservoir 1 along a common axis A, to form a unit (a base/reservoir/capunit). When connected together, the base/reservoir/cap unit is receivedwithin a reservoir receptacle 32 of an infusion pump device 30, alongthe axis A. The axis A in FIG. 1 corresponds to the longitudinal axis ofthe reservoir 1 and of the reservoir receptacle 32, as thebase/reservoir/cap unit is inserted (or aligned to be inserted) into thereservoir receptacle 32. The axis A also corresponds to the central axisof the cap 4 and base 2 in FIG. 1.

When properly installed within the reservoir receptacle 32, the cap 4(or base/reservoir/cap unit) is releasably secured in the housing of ainfusion pump device 30, for example, with the second releasablecoupler. In the embodiment of FIGS. 1 and 2, the second releasablecoupler includes external threads 19 on the housing 5 of the cap 4. Thethreads 19 are arranged to engage corresponding threads (not shown) in areservoir receptacle 32 of the infusion pump device 30 in order tosecure the base/reservoir/cap unit to the infusion pump device 30. Inother embodiments, the second releasable coupler includes other suitablecoupling structures for coupling the cap 4 to the infusion pump device30 in a selectively releasable manner, including but not limited tostructures as described herein with reference to FIGS. 35-75.

Various embodiments described herein employ a reservoir connectionapparatus that includes a cap (such as cap 4 or other cap embodiments)that attaches to a reservoir (such as reservoir 1 or other reservoirembodiments). While the same or different reference numbers are usedherein to designate various cap embodiments (including reference numbers4, 204, 404, 504, 704, 804, 904 a-e, 964, 974, 984, 994, 1004, 1014,1024 and 1050), it will be understood that a cap of any one of thedisclosed embodiments may be employed and operate in a manner the sameor similar to the cap described with respect to another embodimentsherein, where such employment or operation is not inconsistent with theconfiguration of the cap. In addition, it will be understood thatfeatures of a cap of any one of the disclosed embodiments may beincluded or incorporated with or in a cap of any of the other disclosedembodiments and that, where applicable, caps of various embodiments maybe interchanged or modified in accordance with other embodiments. Also,while the same or different reference numbers are used herein todesignate various reservoir embodiments (including reference numbers 1,201 and 301), it will be understood that a reservoir of any one of thedisclosed embodiments may be employed and operate in a manner the sameor similar to the reservoir described with respect to anotherembodiments herein, where such employment or operation is notinconsistent with the configuration of the reservoir.

2. Detection of Reservoir

According to embodiments of the present invention, when the cap 4 (orthe corresponding reservoir/base/cap unit) is received in the infusionpump device 30, the system is configured to detect a proper (orimproper) coupling of the cap 4 (or of the reservoir/base/cap unit) withthe infusion pump device 30. In further embodiments, the sensor anddetectable feature interact in a manner to communicate certaininformation relating to a characteristic of one or more of the reservoir1, reservoir contents, cap 4, infusion set 50 or infusion pump device30.

In other words the detectable feature/sensor combination has one or bothof two primary functions, these being:

(a) to detect the state of closure/seating of the reservoir within thepump; and(b) to convey details of the reservoir/cap/infusion set combination tothe pump.

These two functions can be performed by a single detectablefeature/sensor combination or by respective detectable feature/sensorcombinations performing the individual functions. In the latter case anyof the arrangement hereinafter described for detecting closure may becombined with any of the arrangements for deriving data and thereservoir/cap infusion set combination. For example an RFID arrangementfor conveying data about the reservoir/cap/infusion set combination canbe combined with a magnetic or optical technique to detect closure.

The type of details/data falling within category (b) can either be of aninformation nature, such as the reservoir serial number or a unique IDor can be information to be used by the pump in determining the user'sauthority or the patient dosage, for example, the identity andconcentration of the drug, e.g. insulin or the length, type or size oftubing, which may be relevant for the pump to determine allowable backpressure before an occlusion alarm sounds.

In particular embodiments, one of the cap 4 and the infusion pump device30 is provided with at least one sensor, and the other of the cap 4 andthe infusion pump device 30 is provided with at least one detectablefeature that is detected by the sensor when the cap 4 is properly andoperably coupled with the infusion pump device 30. In furtherembodiments, the cap 4 and the infusion pump device 30 are each providedwith at least one sensor and at least one detectable feature, arrangedto interact with at least one corresponding detectable feature andsensor on the other of the cap 4 and infusion pump device 30. Forexample, the sensor and detectable feature may interact in a manner suchthat the sensor detects the presence or position (or both) of thedetectable feature or other parameters of the detectable feature, whenthe cap 4 is properly received or operatively coupled (or both) with theinfusion pump device 30. As referenced herein, proper receipt oroperative coupling corresponds to a position of the cap 4 (orbase/reservoir/cap unit) at which the drive linkage 1′ of the reservoir1 is operatively engaged with the drive device in the infusion pumpdevice 30. In other embodiments, proper receipt or operative couplingcorresponds to another suitable, predefined position of the cap 4 (orbase/reservoir/cap unit).

In the embodiment of FIG. 1, element 34 represents at least one sensoror detectable feature on the infusion pump device 30, and element 42represents the other of at least one sensor or detectable feature on thecap 4 of the connection interface 40. When the connection interface 40is coupled to the reservoir 1 and the base/reservoir/cap unit is fullyand properly received in the reservoir receptacle 32 of the infusionpump device 30 (as shown in FIG. 3), the element 42 on the cap 4 is insufficient alignment or proximity (or both) with the element 34 to allowthe at least one sensor to detect the at least one detectable feature.However, when the connection interface 40 is not coupled to thereservoir 1, or when the base/reservoir/cap unit is not fully orproperly received in the reservoir receptacle 32 of the infusion pumpdevice 30 (as shown in FIG. 1), the element 42 on the cap 4 is not insufficient alignment or proximity (or both) with the element 34, suchthat the at least one sensor does not detect the at least one detectablefeature.

As discussed above, in various embodiments, element 34 on the infusionpump device 30 is at least one sensor or detectable feature (or both),and element 42 on the cap is at least one of the other of the sensor ordetectable feature (or both). For purposes of clarity in the disclosure,further description of various embodiments refers to the element 34 onthe infusion pump device 30 as at least one sensor, while element 42 onthe cap 4 is referred to as at least one detectable feature. However, itwill be understood that in other embodiments, the element 34 on theinfusion pump device 30 can be at least one detectable feature (or acombination of at least one sensor and at least one detectable feature),while element 42 on the cap 4 can be at least one sensor (or acombination of at least one detectable feature and at least one sensor).

a. Magnetic Detection

As described above, either one of the element 34 or element 42 mayinclude at least one sensor element, while the other of the element 34or element 42 includes at least detectable feature. In particularembodiments, each detectable feature includes one or more magnets, whilethe sensor element is configured to detect the presence or othercharacteristic of a magnet, when in a sufficient proximity or locationrelative to the magnet. Such sensor(s) include, but are not limited to,magnetoresistance (MR), Hall effect, magnetic reed, or other sensordevice that provides a detectable response to the presence or alignment(or both) of a magnet. Magnets include any suitable permanent magnetmaterial. In further embodiments, the magnets include, but are notlimited to, magnetically conductive materials connected with permanentor electromagnets magnets, electromagnets, or other suitable magnetizedmaterial or device.

In particular embodiments, the element 42 on the cap 4 includes at leastone magnet, while the element 34 on the infusion pump device 30 includesat least one sensor. In that embodiment, the cap 4 need not includesensor electronics and, thus, may be made to be more readily disposableafter one use (or a predefined number of uses, a predefined time periodof use, or a combination thereof).

For example, element 42 represents one or more magnets carried by thecap 4 at a predefined location on or in the cap housing, while element34 represents one or more sensors at a predefined location in oradjacent the reservoir receptacle 32 of the infusion pump device 30. Inparticular embodiments, the one or more magnets (element 42) areembedded within the structure of the cap housing, so as to be out ofview and out of contact with users during normal operation of thesystem. In other embodiments, the one or more magnets may be attached toa surface of the cap housing or otherwise secured to the housing of thecap 4.

In particular embodiments, element 34 is a single sensor device, whileelement 42 is a single magnet, where the elements 34 and 42 are arrangedsuch that they come into alignment or proximity (or both) when thebase/reservoir/cap unit is fully or properly received in the reservoirreceptacle 32 of the infusion pump device 30. In other embodiments,element 34 and element 42 comprises a plurality of sensor devices and aplurality of magnets, respectively.

For example, FIGS. 4A and 4B represent an embodiment in which aplurality of elements 42 are arranged on the cap 4, at a correspondingplurality of locations, such that each respective element 42 is at adifferent location on the cap 4 relative to each other respectiveelement 42. The drawings in FIGS. 4A and 4B represent a top-down view ofthe cap 4, to show example locations of elements 42, relative to theaxis A of the cap 4. In the embodiment in FIGS. 4A and 4B, a pluralityof elements 42 (labeled 42A and 42B) are so arranged at differentlocations, spaced circumferentially around or linearly along (or both)the axis A through the center of the cap 4. While FIGS. 4A and 4B showtwo elements 42 (42A and 42B), other embodiments include more than twoelements 42.

In the embodiment of FIGS. 4A and 4B, the element 42A is arranged to bein sufficient alignment or proximity (or both) with the element 34 onthe infusion pump device 30 to allow detection as described above, whenthe base/reservoir/cap unit is fully and properly received in thereservoir receptacle 32, as shown in FIG. 4B. However, another element42B is arranged to be in alignment or proximity (or both) with theelement 34 on the infusion pump device 30 to allow detection asdescribed above, when the base/reservoir/cap unit are not fully orproperly received in the reservoir receptacle 32, as shown in FIG. 4A(for example, but not limited to, when the base/reservoir/cap unit isnot fully rotated or fully inserted (or both) in the reservoirreceptacle 32 to complete the connection of the second releasablecoupler described above). In the embodiment of FIGS. 4A and 4B, whenelement 42A is in detectable alignment or proximity (or both) withelement 34, element 42B is out of detectable alignment or proximity (orboth) with element 34. Similarly, when element 42B is in detectablealignment or proximity (or both) with element 34, element 42A is out ofdetectable alignment or proximity (or both) with element 34.

In the embodiment in FIGS. 4A and 4B, a single element 34 is arranged tobe in alignment or proximity (or both) with each of the plurality ofelements 42 (e.g., 42A and 42B), depending upon the relative position ofthe base/reservoir/cap unit within the reservoir receptacle 32. In otherembodiments, a plurality of elements 34 are arranged (for example, at acorresponding plurality of locations spaced circumferentially orlinearly (or both) around and along the axis A, as represented by thebroken line representations of additional elements 34), to come intoalignment or proximity (or both) with one or more elements 42 atpredefined positions of the base/reservoir/cap unit relative to thereservoir receptacle 32. In those embodiments, the sensor and magnetelements may be arranged to allow detection of various positions of thebase/reservoir/cap unit, as that unit is being received within thereservoir receptacle 32 of the infusion pump device 30.

In particular embodiments in which multiple sensor or multiple magnetelements (or both) are employed on one or both of the cap 4 and infusionpump device 30, the multiple elements may be arranged to allow detectionof various predefined states of the cap 4. Thus, in example embodiments,the multiple elements are arranged spaced apart around the circumferenceof the axis A to allow detection of the rotational position (ormovement) of the cap 4 around the axis A, relative to the infusion pumpdevice 30. Alternatively or in addition, the multiple elements arearranged spaced apart in the axial dimension A of the cap 4 to allowdetection of the linear position (or movement) of the cap 4 along theaxis A, relative to the infusion pump device 30. In other embodiments,one or more elements are arranged to detect angular differences (ormovement) between the axial dimension A of the cap and the axialdimension of the reservoir receptacle 32. Accordingly, in differentembodiments, the sensor element(s) provide one or more sensor signalsrepresenting a rotational position of the cap 4, a linear position ofthe cap 4, an angular position of the cap 4, or any combination thereof.

In further embodiments in which multiple magnet elements are employed,at least two of the magnet elements have mutually different detectableparameters, such as, but not limited to, different magnetic polaritydirections, field strengths, locations or patterns of magnets on thecap, or any combination thereof. In those embodiments, the sensorelement(s) is configured to detect and discern one magnet element fromthe other, based on the detected parameter. In those embodiments, thedifferent magnets (with different detectable parameters) are arranged ata plurality of predefined locations on the cap 4 (or the infusion pumpdevice 30) to be detected by the sensor element(s), as described above,when the cap 4 is in different respective positions within the reservoirreceptacle 32 of the infusion pump device 30.

In particular embodiments, the cap 4 includes one or more magnets thatare integrated into the cap. Example embodiments of a cap 4 are shown inFIGS. 4C and 4D, where the element 42 includes a magnet that isintegrated into the housing 5 of the cap 4. In the embodiments of FIGS.4C and 4D, the magnet (element 42) is secured to and embedded in anouter peripheral surface of the cap housing 5, such that an outersurface of the magnet (element 42) is exposed and faces outward from thecap housing 5. In particular embodiments, the outer surface of themagnet (element 42) has a shape or contour that is similar to the shapeand contour of the outer surface of the cap housing 5 around the magnet(element 42), such that the outer surface of the magnet (element 42) isor appears flush with the outer surface of the cap housing 5. In otherembodiments, one or more magnets (element 42) may be recessed, embedded,molded or otherwise formed inside a wall of the cap housing 5, recessedfrom and not flush with the outer surface of the cap housing 5.

The magnet (element 42) may be secured to the housing 5 of the cap 4 inany suitable manner, including, but not limited to a swaging, mechanicalfitting, adhering with an adhesive material or mechanical connector,soldering, welding, heat staking, molding, co-molding or the like. Forexample, a magnet (element 42) may be molded onto or into the caphousing 5, as part of a process of forming (by molding) the cap housing5, or as a process carried out after forming (by molding or otherwise)the cap housing 5. Such molding processes can include, but are notlimited to, injection molding, molding with an insert mold, molding in amulti-shot (e.g., a two-shot) mold, or other suitable molding processes.

In the embodiment of FIG. 4C, the magnet (element 42) is secured to thehousing 5 by swaging, wherein the magnet (element 42) has been pressedor forced into the surface of the cap housing 5. In the embodiment ofFIG. 4C, a lip 5 a may be formed adjacent one or more sides of themagnet (element 42) due to displacement of some of the material of thecap housing 5 during a swaging process. In a particular embodiment, ahot swaging procedure is employed, in which a magnet (element 42) issintered or hot-pressed into the cap housing 5. In other embodiments, acold swaging procedure is employed, or a combination of hot and coldswaging is employed to secure the magnet (element 42) to the cap housing5.

In the embodiment of FIG. 4D, the magnet (element 42) is secured to thehousing 5 by a mechanically fitting the magnet (element 42) in adepression formed in the cap housing 5. In FIG. 4D, the magnet (element42) has a size and shape that matches or corresponds to the size andshape of the depression in the cap housing 5. In particular embodiments,as shown in FIG. 4D, the magnet (element 42) has a shape that flaresoutward or widens in the direction toward the axis A, and the depressionin the cap housing 5 is correspondingly shaped to flare or widen in thedirection toward the axis A. In such embodiments, the width of themagnet (element 42) in the circumferential direction of the cap housing5 is smaller at the outer or exposed surface of the magnet (element 42)than at the inner surface (the surface of the magnet (element 42) thatfaces toward the axis A). Also, in such embodiments, the width of theinner surface (the surface of the magnet (element 42) that faces towardthe axis A) may be selected to be greater than the width of theoutward-facing end of the depression in the cap housing 5, so as to helpretain the magnet (element 42) within the depression. In furtherembodiments, one or more additional mechanisms as described above may beemployed in combination with a mechanical fit, to further help retainthe magnet (element 42) within the depression, including but not limitedto swaging, adhering with an adhesive material or mechanical connector,soldering, welding, heat staking, molding, co-molding or the like.

In further embodiments, the magnet (element 42) may be secured to thecap 4 in any other suitable manner. In embodiments as described herein,when the cap 4 (or base/reservoir/cap unit) is installed within thereservoir receptacle 32 of the infusion pump device 30, the magnet(element 42) is located in a position for magnetic detection by or otherinteraction with the sensor element (element 34) located on the infusionpump device 30. In particular embodiments, the sensor element (element34) and associated electronics 60 (FIG. 5) are configured to detect oneor more of the presence, position (axially rotational, angular and/orlinear) of the cap 4 (or base/reservoir/cap unit) within the reservoirreceptacle 32 of the infusion pump device 30.

To illustrate how multiple sensors and multiple magnetic elements canlead to a more accurate detection of the angular position of a cap in aninfusion pump device reference is again made to FIGS. 4A and 4B. For thepurpose of this example multiple sensors 34 are positioned around theinside of a reservoir receptacle 32 of a pump device as shown in FIG. 1.The angular spacing of the sensors 34 is referred to as an angle theta.For the purpose of this discussion the sensors 34 will be counted in ananticlockwise direction starting from the sensor shown with the unbrokenline. On the cap, magnets 42 are shown arranged at angular positionssuch that when one magnet, for example, 42 a is aligned with the sensorthe next magnet in an anticlockwise direction lies exactly at a midwayposition between the two subsequent sensors. The angular spacing of thesecond magnet from the first magnet to achieve this would be one and ahalf theta.

Considering now the operation, FIG. 4A shows the situation in which thecap is open i. e. unlocked. In this situation the second magnet 42B isaligned with the first sensor 34 and the first magnet 42A is out ofrange of any of the three sensors illustrated in FIG. 4A. The cap isthen manually closed by rotating about the axis A in an anticlockwisedirection until it reaches the condition shown in FIG. 4B in which thefirst magnet 42A is aligned with the first sensor 34. Such alignmentwould be detected by the first sensor 34 as a maximum in the magneticfield strength. As the rotation of the cap approaches the position shownin 42B so the second magnet 42B passes the second sensor 34 (countinganticlockwise from the sensor shown as a solid line) and progressestowards the third sensor. As the second magnet 42B passes the secondsensor the magnetic field strength detected at the second sensorincreases and then decreases. As it approaches the third sensor 34 themagnetic field strength detected by that third sensor increases. Whenthe second magnet 42B is exactly midway between the second and thirdsensors they will each detect an equal magnetic field. The position ofthe equal magnetic field corresponds exactly to the alignment positionof the first magnet 42A with the first sensor (shown as a solid line)which is the closed/locked position.

Accordingly, the more accurate closed position can be detected by anexact match between the outputs of the second and third sensors. Thesituation shown in FIGS. 4A and 4B is with two magnets. Adding a thirdmagnet at a spacing of theta from the second magnet and a fourth sensoralso at a spacing of theta from the third sensor would improve thesensitivity further.

A yet further refinement of this system would be to arrange the firstmagnet 42A on the cap to have an opposite polarity to the second magnet42B. In the simplest case this would enable the first sensor 34 (whereonly one sensor is provided) to distinguish immediately between the openposition shown in FIG. 4A where one pole is presented to the sensor 34from the position in FIG. 4B where the opposite pole is presented.

In a situation with multiple sensors and magnets in which the sensorsare equally spaced with an angle theta and the magnets are spaced fromthe first magnet 42A by an angle of one half (2n+1) theta and withalternating pole polarities in the magnets starting from the firstmagnet 42A and progressing in an anticlockwise direction the closedposition would be detected when the first magnet 42A aligns with thefirst sensor 34 and the second magnet 42B is equidistant between thesecond and the third sensors 34 and the third magnet (not shown) isequidistant between the third and the fourth sensors. In this situationthe magnetic fields from the second and third magnets would cancel atthe third sensor and the magnetic fields detected by the second andfourth sensors would be of equal and opposite polarity. The exactmid-position, hence closed position of FIG. 4B, can then be detected asthe position in which the sum of the magnetic fields detected by thesecond, third and fourth sensors is zero. This manner of detection isalso immune to external magnetic fields.

FIG. 4E shows cross-section view of an example of a cap 4 (andbase/reservoir/cap unit) with an integrated magnet (element 42),installed within the reservoir receptacle 32 of an infusion pump device30. In the embodiment of FIG. 4E, the sensor element (element 34) islocated on an electronic circuit board (PCB) 41, and/or within a stackof electronic components or electronic circuit boards, within thehousing 33 of the infusion pump device 30. Associated electronics (e.g.,electronics 60 in FIG. 5) may be located on the same electronic circuitboard or stack, or on a different electronic circuit board or stackwithin the housing 33 of the infusion pump device 30. The sensor element(element 34) and associated PCB 41 (or electronic component stack) arelocated within the infusion pump device 30, in sufficient proximity tothe reservoir receptacle 32 for detection or other interaction with themagnet (element 42), when the cap 4 (or base/reservoir/cap unit) isinstalled within the reservoir receptacle 32.

In the embodiment in FIG. 4E, the magnet (element 42) may be affixed toor otherwise integrated into the housing of the cap 4, as describedherein. The magnet (element 42) is selected to have sufficient strengthand magnetization, such that a magnetic field created by the magnet(element 42) can be detected and, in particular embodiments, measured bythe sensor element (element 34). The sensor element (element 34) may becontained within the housing 33 of the infusion pump device, at alocation sufficiently proximal to the cap 4, to detect or otherwiseinteract with the magnet (element 42). In particular embodiments, thesensor (element 34) and associated electronics (e.g., electronics 60 inFIG. 5) are activated during an installation or setup process in which anew cap 4 (or base/reservoir/cap unit) is installed in the infusion pumpdevice 30.

In such embodiments, the sensor (element 34) or a separate dedicatedsensor (not shown) may be configured to detect installation activities(such as, but not limited to, an insertion of a cap 4 (orbase/reservoir/cap unit) into the reservoir receptacle) or an activationof a designated manual operator (e.g., manually activated by the userduring setup). Upon detection of an installation activity, the sensor(element 34) and associated electronics are activated to poll or readcontinuously or intermittently, to seek a magnetic field or signaturefrom a magnet (element 42). Upon detection (or other interaction) with amagnet (element 42), the sensor element (element 34) and associatedelectronics may be configured to read magnetic field information todetermine one or more of a presence, connection state, position, orother detectable parameter associated with the cap 4 (orbase/reservoir/cap unit).

Thus, in particular embodiments, the infusion pump device 30 may beconfigured to have a useful life that is significantly greater than theuseful like of the cap 4 (or base/reservoir/cap unit). In suchembodiments, a cap 4 (or base/reservoir/cap unit) may be installed,replaced with a new or different cap (or base/reservoir/cap unit), orre-installed in the infusion pump device 30, as appropriate. Particularembodiments are configured such that electronics (e.g., electronics 60in FIG. 5) can determine and differentiate between different caps (orbase/reservoir/cap units), including different models or different typesof caps (or base/reservoir/cap units), and/or can authenticate a cap (orbase/reservoir/cap unit) as an authorized component (e.g., authorizedfor use with the infusion pump device 30, and/or user). Particularembodiments are configured such that information read by the sensorelement (element 34) may be processed by electronics (e.g., electronics60 in FIG. 5) to detect a connected state of the cap 4 (orbase/reservoir/cap unit) with the infusion pump device 30. Suchinformation may also be used to detect a dislodgment or other undesiredmovement of the cap 4 (or base/reservoir/cap unit) relative to thereservoir receptacle 32 of the infusion pump device 30, for example,caused by rigorous exercise or other rigorous motion of the user. Agraph showing an example of a plot of magnetic flux density as afunction of engagement angle of a cap 4 relative to the axis A is shownin FIG. 4F.

FIG. 4F is a graph showing how a magnet in the cap is detected aslatched and unlatched through an angular rotation of 360 degrees. Ituses a simple arrangement with one detector 34 and one magnet 42essentially as shown in FIGS. 1 to 3. The correct angular position ofthe cap is detected based on the measured magnetic filed strength at thedetector. The upper horizontal broken line represents the field strengthto indicate no latching (e.g., the cap is not in the right position oris loose). The lower broken horizontal line indicates the field strengthwhere latching is present (e.g., the cap is in the right position). Thetwo curves represent the magnet strength based on design tolerances thatlocate the magnet closer or further from the sensor. The upper curverepresents what would be expected if tolerances stack up to keep themagnet far from the sensor. The lower curve represents when thetolerances stack up to bring it closest to the sensor. Both curves showthat even with tolerances, detection of the correct position andlatching can be determined, since both curves exceed the “present” orreservoir IN criteria close to 0 degrees.

In particular embodiments, one or more detectable parameters of themagnetic field of a magnet (element 42) may be associated with one ormore characteristics of the cap 4 (or other component of thebase/reservoir/cap unit), infusion set, infusion pump device 30, user.For example, the shapes, sizes, grades, materials, direction ofmagnetization, and other properties of magnets (elements 42) caninfluence detectable parameters of the magnetic fields provided by suchmagnets (elements 42). Accordingly, embodiments are configured such thatthe output of the sensor (element 34) is dependent on one or moredetectable parameters of the magnetic field of the magnet (element 42).In particular embodiments, the one or more detectable parameters of themagnet (element 42) on a given cap 4 (or base/reservoir/cap unit)provides a signature that is distinguishable from one or more othermagnets (elements 42) on one or more other caps (or base/reservoir/capunit). Thus, each different cap 4 (or base/reservoir/cap unit) can havea different detectable signature relative to each other cap 4 (orbase/reservoir/cap unit). Alternatively, groups or classes of multiplecaps 4 (or base/reservoir cap units) can have the same or similarsignature as other caps 4 (or base/reservoir/cap units) in the samegroup or class, but have different detectable signature from one or more(or all) caps (or base/reservoir/cap units) in one or more (or all)other groups or classes.

In one embodiment, a property of the magnet (element 42) that isselected or configured for detection is the magnet grade. In suchembodiments, different caps 4 (or base/reservoir cap units), ordifferent groups of caps 4 (or base/reservoir cap units) can have adifferent grade of magnet than other caps 4 (or base/reservoir/capunits) or other groups of caps 4 (or other groups of base/reservoir/capunits). For example, caps 4 (or base/reservoir/cap units) havingrespectively different grades of magnets (elements 42) can providesignatures that are the same shape, but respectively different inamplitudes. Thus, in particular embodiments, one or more characteristicsof the cap 4 (or base/reservoir/cap unit), infusion set, infusion pumpdevice, or user is associated with a grade of magnet (element 42) or itsassociated amplitude signature.

In another embodiment, a property of the magnet (element 42) that isselected or configured for detection is the magnet shape and/or themagnet size. In such embodiments, different caps 4 (or base/reservoircap units), or different groups of caps 4 (or base/reservoir cap units)can have a different magnet shapes or sizes than other caps 4 (orbase/reservoir/cap units) or other groups of caps 4 (or other groups ofbase/reservoir/cap units). For example, caps 4 (or base/reservoir/capunits) having respectively different sizes or shapes of magnets(elements 42) can provide signatures that are different directions,shapes and/or amplitudes. Thus, in particular embodiments, one or morecharacteristics of the cap 4 (or base/reservoir/cap unit), infusion set,infusion pump device, or user is associated with a shape or size ofmagnet (element 42) or its associated amplitude signature.

Examples of different magnet shapes that provide different magnet fielddirections or shapes are shown in FIG. 4G. Particular embodiments employone or more magnets (elements 42) having one or more shapes as shown inFIG. 4G. In other embodiments, a magnet (element 42) may have adifferent shape, with respect to those shown in FIG. 4G. The shape andconfiguration of the magnet can determine the polarity or fielddirection or shape, as represented by the arrows 43 in FIG. 4G, where,for example, the arrow head is on a side of the magnet (element 42) thatrepresents a north magnetic pole. Thus, for example, the magnetconfigurations in FIG. 4G can provide a detectable field direction orshape that is diametrical, radial, parallel to the length of the magnet(element 42), parallel to the thickness of the magnet (element 42),radial through an arc segment, or a combination of multiple poles. Inparticular embodiments, the sensor (element 34) and associatedelectronics (e.g., electronics 60 in FIG. 5) are configured to detectand differentiate one magnet (element 42) from another, based, at leastin part, on the direction or shape of the magnetic field signature.Thus, in particular embodiments, one or more characteristics of the cap4 (or base/reservoir/cap unit), infusion set, infusion pump device, oruser is associated with a shape of magnet (element 42) and itsassociated magnetic field direction or shape.

In another embodiment, a property of the magnet (element 42) that isselected or configured for detection is the polarity or magnetic fielddirection. In particular embodiments, the sensor (element 34) isconfigured to provide a first output when in detectable presence of amagnet (element 42) having a first field direction, and a second outputwhen in detectable presence of a magnet (element 42) having a secondfield direction that is opposite to the first field direction. Forexample, the sensor (element 34) may be configured to detect anddifferentiate between a magnet having a south facing (seeking) pole anda magnet having a north facing (seeking) pole.

In such embodiments, different caps 4 (or base/reservoir cap units), ordifferent groups of caps 4 (or base/reservoir cap units) can have adifferent magnet pole directions than other caps 4 (orbase/reservoir/cap units) or other groups of caps 4 (or other groups ofbase/reservoir/cap units). For example, one or more caps 4 (orbase/reservoir/cap units) having magnets (elements 42) with north polesdirected in a first direction can provide signatures that are detectablydifferent from one or more (or all) other caps 4 (or base/reservoir/capunits) having magnets (elements 42) with south poles directed in thefirst direction. In such embodiments, different caps 4 (or differentbase/reservoir/cap units or associated infusion sets) can employ thesame magnet shape and size, but arranged in different pole directions.Thus, in particular embodiments, one or more characteristics of the cap4 (or base/reservoir/cap unit), infusion set, infusion pump device, oruser is associated with a pole direction of the magnet (element 42).

Thus, for example, with reference to the partial cross-section view ofthe cap 4 (or base/reservoir/cap unit) and the infusion pump device 30in FIG. 4H, the cap 4 has a magnet (element 42) that is arranged withits north pole facing upward in the drawing. In contrast, the partialcross-section view of the cap 4 (or base/reservoir/cap unit) and theinfusion pump device 30 in FIG. 4I shows the cap 4 (orbase/reservoir/cap unit) with a magnet (element 42) that is arrangedabout 180 degrees opposite to the magnet (element 42) in FIG. 4H, suchthat its south pole is facing upward in the drawing. In otherembodiments, the cap 4 (or base/reservoir/cap unit) may include a magnet(element 42) that is arranged with its north pole facing in a selecteddetectable direction that is less than or more than 180 degrees oppositeto the magnet (element 42) in FIG. 4H. As shown by the direction ofarrows in FIGS. 4H and 4I, the different orientations of the north poleside of the magnet (element 42) in those drawings provides differentmagnetic field directions relative to each other. In such embodiments,the sensor element (element 34) is configured to detect anddifferentiate the direction of the magnetic field.

Accordingly, in particular embodiments, one or more of the shapes,sizes, grades, materials and other properties of magnets (elements 42)provides detectable parameters or a signature that is associated withone or more predefined characteristics of the cap 4 (or other componentof the base/reservoir/cap unit), infusion set, infusion pump device 30,user. In particular embodiments a combination of such magnet propertiesare selected or associated with one more characteristics of the cap 4(or other component of the base/reservoir/cap unit), infusion set,infusion pump device 30, or user.

Certain embodiments in FIGS. 4C-I include magnets (elements 42) having aparticular three-dimensional shape. In other embodiments, one or moremagnets (as element 42) is configured in the form of a magnetic strip, astrip of magnetic material, or a strip of material having one or morediscrete or continuous magnets along a length dimension of the strip. Inparticular embodiments, the magnet (element 42) includes a readablestrip, similar to magnetic strips employed on credit cards, but embeddedwith information or codes associated with one more characteristics ofthe cap 4 (or other component of the base/reservoir/cap unit), infusionset, infusion pump device 30, or user.

Particular embodiments are configured to allow detection of differentcharacteristics of a the cap 4 (or other components of thebase/reservoir/cap unit or connected infusion set), based on one or moredetected parameters of the magnet (element 42). In certain embodiments,such characteristics may include, but are not limited to, the type orfeatures of the infusion set that is connected to the cap 4. Forexample, a cap (or base/reservoir/cap unit) may be configured to connectwith a variety of different infusion set products (such as, but notlimited to the following infusion set products: Quick-set® infusion set,Silhouette® infusion set, Sure-T® infusion set, Mio® infusion set, orthe like). In addition, different infusion sets may be configured with avariety of different feature options for meeting user needs orpreferences, such as, but not limited to, tubing length, cannula lengthand cannula type. In particular embodiments, different infusion sets,features and options may be associated with different respecteddetectable parameters of the magnet (element 42) and, thus,differentiated based on detected parameters of the magnet (element 42).

The sensor (element 34) in particular embodiments described herein mayinclude one or more Hall effect sensors or other suitable devices, thatvaries an output voltage in response to changes in a magnetic field.Such sensors can be contained in a suitably sealed package that inhibitspassage of dust, dirt, mud or water from the external environment to thesensor electronics. Such sensors can be configured in a surface mountpackage, in a single in-line package, or other suitable arrangement, forexample, mounted on a circuit board within the infusion pump device 30,at a location that is sufficiently adjacent and oriented relative to themagnet (element 42) for proper detection when the cap (orbase/reservoir/cap unit) is installed on the infusion pump device 30.

For maximizing sensitivity of a Hall effect sensor, it can be desirableto arrange the magnet (element 42) such that, during detectionoperations, flux lines of the magnet (element 42) are perpendicular (orgenerally perpendicular) to a sensing area of the Hall effect sensor,e.g., a defined surface area (or plane) of a semi-conductor material inthe sensor. In addition, the size of the magnet (element 42) and itsproximity to the sensor (element 34) may be selected for improveddetection sensitivity.

In particular embodiments, the magnet (element 42) may be configured inthe shape of a segment of an arc, but is magnetized and oriented in amanner to provide higher flux density in a selected direction toaccommodate a desired position of the sensor (element 34), or a desiredposition of a circuit board on which the sensor (element 34) is mounted.

For example, an arc-shaped magnet (element 42) that is magnetizedthrough its circumference is shown in FIG. 4J. The drawing in FIG. 4Kshows an arrangement of the magnet (element 42) of FIG. 4J relative to acircuit board (e.g., PCB 41) in an infusion pump device (not shown inFIG. 4K). As shown in FIG. 4K, a Hall effect sensor (element 34) may bearranged with its sensor plane arranged perpendicular (or generallyperpendicular) to the magnetic field flux lines produced by the magnet(element 42) of FIG. 4J for maximized sensor output when the cap 4 (orbase/reservoir/cap unit) (not shown in FIG. 4K) is in an installedposition within the infusion pump device 30. The circumferentiallymagnetized magnet (element 42) in FIG. 4K provides a relatively highdensity of flux in the Z-axis direction of the drawing. Accordingly, inthe embodiment in FIG. 4K, the sensor plane of the Hall effect sensor(element 34) is arranged parallel to the plane of the surface of thecircuit board (e.g., PCB 41) on which the sensor (element 34) ismounted, such that the sensor plane is perpendicular to the Z axis inthe drawing.

Another example of an arc-shaped magnet (element 42) is shown in FIG.4L, where the magnet (element 42) is radially magnetized such that theNorth pole of the magnet (element 42) faces radially outward, while theSouth pole of the magnet (element 42) faces radially inward. In furtherembodiments, a leaded package is used in conjunction with a radiallymagnetized magnet (element 42), for improved flux direction control.

The drawing in FIG. 4M shows an arrangement of the magnet (element 42)of FIG. 4L relative to a circuit board (e.g., PCB 41) in an infusionpump device 30. As shown in FIG. 4M, a Hall effect sensor (element 34)may be arranged with its sensor plane perpendicular (or generallyperpendicular) to the magnetic field flux lines produced by the magnet(element 42) of FIG. 4L for maximized sensor output when the cap 4 (orbase/reservoir/cap unit) is in an installed position within the infusionpump device 30. The radially magnetized magnet (element 42) in FIG. 4Mprovides a relatively high density of flux in the X-axis direction ofthe drawing. Accordingly, in the embodiment in FIG. 4M, the sensor planeof the Hall effect sensor (element 34) is arranged parallel to the planeof the surface of the circuit board (e.g., PCB 41) on which the sensor(element 34) is mounted, such that the sensor plane is perpendicular tothe X axis in the drawing.

Another example of an arc-shaped magnet (element 42) is shown in FIG.4N, where the magnet (element 42) is axially magnetized such that theNorth pole of the magnet (element 42) faces axially upward in thedrawing, while the South pole of the magnet (element 42) faces axiallydownward in the drawing. In further embodiments, a leaded package isused in conjunction with a radially axially magnet (element 42), forimproved flux direction control.

The drawing in FIG. 4O shows an arrangement of the magnet (element 42)of FIG. 4N relative to a circuit board (e.g., PCB 41) in an infusionpump device 30. As shown in FIG. 4O, a Hall effect sensor (element 34)may be arranged with its sensor plane perpendicular (or generallyperpendicular) to the magnetic field flux lines produced by the magnet(element 42) of FIG. 4N for maximized sensor output when the cap 4 (orbase/reservoir/cap unit) is in an installed position within the infusionpump device 30. The axially magnetized magnet (element 42) in FIG. 4Nprovides a relatively high density of flux in the Y-axis direction ofthe drawing. Accordingly, in the embodiment in FIG. 4O, the sensor planeof the Hall effect sensor (element 34) is arranged parallel to the planeof the surface of the circuit board (e.g., PCB 41) on which the sensor(element 34) is mounted, such that the sensor plane is perpendicular tothe Y axis in the drawing.

In any of the embodiments of FIGS. 4J-4O, a leaded package may be usedin conjunction with the magnet (element 42), for improved flux directioncontrol. Furthermore, in any of the embodiments in FIGS. 4J-4O, the Halleffect sensor (or the circuit board on which the sensor is mounted) maybe rotated or otherwise adjusted relative to the orientations shown inFIGS. 4K, 4M and 4O, for improved performance or space considerationswithin the infusion pump device (or both). In particular embodiments,the Hall effect sensor (element 34) may be mounted on a second board orsubassembly (relative to other electronics), for improved flexibility inpositioning or orientating the sensor.

Accordingly, in particular embodiments, the magnetization orientation ofthe magnet (element 42) may be selected (e.g., from amongcircumferential, radial, axial or other suitable orientations), toaccommodate a desired position or orientation of the sensor (element 34)in the infusion pump device 30 (or a desired position or orientation ofthe circuit board on which the sensor (element 34) is mounted).

In further embodiments, the sensor (element 34) is configured to detectand differentiate between different magnetization orientations (e.g.,from among circumferential, radial, axial or other suitableorientations) of magnets (elements 42) on different caps 4 (orbase/reservoir/cap units). Thus, in particular embodiments, theorientation or direction of magnetization of the magnet (element 42)relative to a particular orientation and direction of the sensor planeof the sensor (element 34), or of the plane of the circuit board onwhich the sensor (element 34) is mounted, is a detectable parameter thatcan be associated with one or more characteristics of the cap 4 (or thebase/reservoir/cap unit or the infusion set connected to the cap 4).

A Hall effect sensor can operate as an analog transducer, directlyreturning a voltage that is proportional to the applied magnetic field,and can be sensitive to both positive and negative fields. A linear Halleffect sensor can provide a linear response as shown in the graph ofFIG. 4P, by applying a fixed offset (null voltage) to the output of thesensor when no magnetic field is present. When a positive field ispresent, the voltage output increases above the null voltage until theoutput of the sensor is saturated. Similarly, when a negative field ispresent, the voltage output is decreased below the null voltage untilthe output of the sensor is saturated. Thus, according to particularembodiments, the null voltage and sensor (element 34) output may be usedto differentiate between a South pole and a North pole of a magnet(element 42) and, thus, to differentiate a radially magnetized magnet(element 42) having a North pole facing radially outward (as shown inFIG. 4L), from a radially magnetized magnet (element) having a Southpole facing radially outward (not shown). Accordingly, a cap 4 (orbase/reservoir/cap unit) having a magnet (element 42) with a North polefacing radially outward may be detectably differentiated from anothercap 4 (or base/reservoir/cap unit) having a magnet (element 42) with aSouth pole facing radially outward. Thus, in particular embodiments, theorientation or direction of magnetization is a detectable parameter thatcan be associated with one or more characteristics of the cap 4 (or thebase/reservoir/cap unit or the infusion set connected to the cap 4). Forexample, characteristics associated here may be a 7-day infusion set vs.a 3-day infusion set, or a DUO® set (combination infusion and sensorset) vs. a non-DUO® set. Moreover, due to the linear response detectedby a Hall effect sensor, whether a cap 4 (or base/reservoir/cap unit) isproperly rotated and seated/secured into the infusion pump device alsomay be determined as a user installs a cap 4 by detecting the linearresponse from the null voltage state (e.g., beginning of installation)to a saturation voltage state (properly seated/secured). The progress ofinstallation (e.g., the cap 4 is 10%, 28%, 65%, 90%, etc.inserted/rotated away from full/complete installation) or just anincomplete installation status/loose cap may be detected along thelinear response between the null voltage and the saturation voltage.

In further embodiments, a Hall effect sensor (element 34) includes or iscoupled with electronic circuitry that allows the sensor to operate withdigital (on/off) switch modes as a digital Hall effect sensor. Suchelectronic circuitry may be in or associated with an electronic circuitconnected with the sensor (element 34) as described with reference toFIG. 5, and may include a Schmitt trigger circuit connected to theoutput of the sensor (element 34). As shown in FIG. 4Q, a hysteresis maybe provided in the switching operation, to avoid bouncing between on andoff states. In such embodiments, the magnetic field on the sensor(element 34) increases as a magnet (element 42) on a cap 4 orbase/reservoir/cap unit is moved into proximity of the sensor (element34) during or upon installation of the cap 4 (or base/reservoir/capunit) in the infusion pump device 30. However, the output does notchange until the operating point is exceed and the sensor is switched toan on state. Further increases in the magnetic field beyond the operatepoint does not affect the sensor output. If the magnet field isdecreased below the operate point (e.g., as the magnet (element 42) ismoved away from the sensor (element 34)), the sensor output will not beaffected until a release point is reached, at which the sensor isswitched to an off state.

A digital Hall effect sensor (element 34) according to particularembodiments may include a unipolar sensor that employs a single polarityto both operate and release, as the magnetic field moves in or out ofrange (e.g., as the magnet (element 42) is moved toward or away from thesensor (element 34)). Such unipolar can be configured to be sensitive toone of either a North magnetic pole or a South magnetic pole.

A digital Hall effect sensor (element 34) according to furtherembodiments may include an omnipolar sensor that operates with either aNorth magnetic pole or a South magnetic pole. Such omnipolar sensors canbe turned On when in a magnetic field of sufficient strength and remainson until the magnetic field is removed. With an omnipolar sensor, themagnet (element 34) may be mounted with either the North pole or theSouth pole facing outward, which can simplify manufacturing processes.

Yet further embodiments employ a bipolar digital Hall effect sensor(element 34) that operates to turn On (from an Off state) when in thepresence of a sufficiently strong magnetic field of a first polarity(such as, but not limited to South), and then to turn Off (from an Onstate) when in the presence of a sufficiently strong magnetic field of asecond polarity (such as, but not limited to North). In otherembodiments, a bipolar digital Hall effect sensor (element 34) isemployed to discriminate between North and South poles based on adetected magnetic field, to determine the polarity direction of a magnet(element 42) in the range of the sensor (element 34). Thus, inparticular embodiments, bipolar digital Hall effect sensors (elements34) are employed to provide the capability to differentiate betweendifferent infusion sets or other characteristics of the cap 4 (or of thebase/reservoir/cap unit or the infusion set connected to the cap 4). Forexample, a cap 4 (or base/reservoir/cap unit) having a magnet (element42) that has a first polarity direction (such as, but not limited toNorth facing upward or outward) may include one or more first predefinedcharacteristics (such as, but not limited to, a first type of infusionset), while a cap 4 (or base/reservoir/cap unit) having a magnet(element 42) that has a second polarity direction (such as, but notlimited to South facing upward or outward) may include one or moresecond predefined characteristics different from the first predefinedcharacteristic (such as, but not limited to, a second type of infusionset that is different from the first type).

In further embodiments, the sensor (element 34) described herein mayinclude one or more Magneto-Resistive (MR) or AnisotropicMagneto-Resistive (AMR) sensors or other suitable devices that employ aparamagnetic material. Embodiments of such MR or AMR sensors may bearranged in a Wheatstone Bridge (or series of Wheatstone Bridges), tosense changes in the resistance of the paramagnetic material resultingfrom an incident magnetic field. In particular embodiments, such sensorarrangements may provide a maximum resistance value when the directionof the current is parallel to an applied magnetic field, providing anull or zero output voltage. In further embodiments, such devices mayprovide an output voltage that varies with the direction of the incidentmagnetic field, such that an incident angle of the magnetic field can bedetected and differentiated. In such embodiments, the magnetic fieldincident angle can be a detectable parameter that is associated with oneor more predefined characteristics of the cap 4 (or thebase/reservoir/cap unit or the infusion set connected to the cap 4) thatcarries the magnet (element 42) producing the incident field.

Alternatively, or in addition, an MR or AMR sensor (element 34) candetect and differentiate between different magnitudes of incidentmagnetic fields. In such embodiments, the magnetic field magnitude canbe a detectable parameter that is associated with one or more predefinedcharacteristics of the cap 4 (or the base/reservoir/cap unit or theinfusion set connected to the cap 4) that carries the magnet (element42) producing the incident field.

In particular embodiments, an MR or AMR sensor (element 34) is connectedto operate with digital (on/off) switch modes, similar to the digitalHall effect sensor embodiments described above. However, for maximizingsensitivity of a MR or AMR sensor, it can be desirable to arrange themagnet (element 42) such that, during detection operations, flux linesof the magnet (element 42) are in or parallel to (or generally parallelto) a sensing area of the sensor, e.g., a defined surface area (orplane) of a paramagnetic material in the MR or AMR sensor. For example,an AMR sensor (element 34) may be arranged on a planar surface of acircuit board that faces similar to the direction of the circuit board41 in FIG. 4O.

FIGS. 4R and 4S are graphs representing examples of outputs of an AMRsensor (element 34) upon movement of the magnet (element 42) relative tothe sensor (element 34). With reference to FIGS. 4R and 4S, thesensitive axis 71 of the MR or AMR sensor (element 34) can be arranged,relative to the position and orientation of the magnet (element 42) whenthe cap 4 (or base/reservoir/cap unit) (not shown in FIGS. 4R and 4S) isin an installed position within the infusion pump device 30, toaccommodate desired sensitivity and operation. For example, by orientingthe MR or AMR sensor (element 34) with its sensitive axis 71 parallel tothe direction of magnetization of the magnet (element 42), as shown inFIG. 4R, the magnetic field is nearly perpendicular to the sensitiveaxis 71 when the relative position of the magnet (element 42) and thesensor (element 34) is such that a pole of the magnet (element 42) isnear the sensor (element 34).

As relative motion of the magnet (element 42) and the sensor (element34) occurs in the direction of the sensitive axis 71, the output of thesensor (element 34) changes toward a maximum output level, where themaximum output is provided when the magnet (element 42) is positionedsuch that the sensor (element 34) is at the midpoint between the Northand South poles of the magnet (element 42). The U-shaped curve 73 inFIG. 4R represents an output voltage level of the MR or AMR sensor(element 34) having a sensitive axis 71 that is parallel to thedirection of magnetization of the magnet (element 42), as the relativeposition of the magnet (element 42) and the sensor (element 34) changesin the direction of the sensitive axis 71 of the sensor. Such an outputresponse can be employed, for example, to provide a presence detectionoperation, in which the detection of a voltage output as shown in FIG.4R is associated with a determination that a cap 4 (orbase/reservoir/cap unit) is in an installed position within the infusionpump device 30.

Alternatively, by orienting the MR or AMR sensor (element 34) with itssensitive axis 71 perpendicular to the direction of magnetization of themagnet (element 42), as shown in FIG. 4S, the sensor outputdifferentiates between the North and South poles of the magnet (element42). Accordingly, an embodiment as shown in FIG. 4S can be employed fordetection of the presence of the magnet (element 42), as well as theparticular polar orientation of the magnet (element 42), when the cap 4(or base/reservoir/cap unit) is in an installed position within theinfusion pump device 30.

For example, with reference to the arrangement in FIG. 4S, as therelative position of the magnet (element 42) and the sensor (element 34)is such that the North pole of the magnet (element 42) is located nearthe sensor (element 34), the magnetic field is nearly aligned with orparallel to the sensitive axis 71 of the sensor (element 34), such thatthe sensor output is maximized. As the relative position of the magnet(element 42) and the sensor (element 34) change such that the sensor(element 34) is located at the midpoint between the two poles of themagnet (element 42), the magnetic field is nearly perpendicular to thesensitive axis 71 of the sensor (element 34), resulting in a nullvoltage output. As the relative position of the magnet (element 42) andthe sensor (element 34) change such that the sensor (element 34) islocated near the South pole of the magnet (element 42), the magneticfield of the magnet (element 42) is again aligned with the sensitiveaxis 71 of the sensor (element 34), but in the opposite direction of thesensitive axis, such that the sensor output becomes minimum. TheS-shaped curve 75 in FIG. 4S represents an output voltage level of theMR or AMR sensor (element 34) having a sensitive axis 71 that isperpendicular to the direction of magnetization of the magnet (element42), as the relative position of the magnet (element 42) and the sensor(element 34) changes in the direction of the sensitive axis 71 of thesensor. Accordingly, the sensor output can be employed for detection ofthe presence of the magnet (element 42), as well as the particular polarorientation of the magnet (element 42), when the cap 4 (orbase/reservoir/cap unit) is in an installed position within the infusionpump device 30.

Similar arrangements and outputs can be described for Hall effectsensors (as element 34), as described above. However, an S-shaped curvesimilar to curve 75 in FIG. 4S would be produced with a Hall effectsensor having a sensitive axis arranged parallel to the direction ofmagnetization of the magnet (element 42), while a U-shaped curve similarto curve 73 in FIG. 4R would be produced with a Hall effect sensorhaving a sensitive axis arranged perpendicular to the direction ofmagnetization of the magnet (element 42).

According to further embodiments of the present invention, acompass-type sensor element (such as a magnetometer) may be utilized inplace of, or in addition to, the sensor element (element 34) in theinfusion pump device 30. The compass-type sensor element may be one usedpopularly in mobile phones that provide compass functionality to themobile phone via a Compass App, such as in the APPLE® IPHONE®. Thecompass-type sensor element may be configured to interact with a compasssensor detectable feature element, such as, but not limited to a magnet(element 42), a concave or circular (magnetic/metallic) disk, or anysuitable component or shape or combination thereof that produces amagnetic field that acts as an “Earth” to the compass-type sensorelement, such that depending on the orientation of the compass sensordetectable feature element that is arranged on the cap 4 (and/or base,reservoir, tubing, etc.), a resolution of 360 degrees, finer or coarser,may be possible. Such embodiments can provide further ways todifferentiate between various caps 4 (and/or base, reservoir, tubing,etc.) that may be available to the user and automatically detectable bythe infusion pump device 30.

In particular embodiments, detectable resolutions (degrees or ranges ofdegrees) can be parameters that are associated with differentcharacteristics of the cap 4 (or other components of the base/reservoircap unit or connected infusion set), where such associations can bestored in electronic memory and employed by processing electronics (suchas, but not limited to memory 66 and processing electronics 62 ofelectronic circuit 60) as described below with respect to FIGS. 5 and 6.For example, associations of different resolution degrees with differenttubing length (for tubing 52 of the infusion set 50) can be stored suchthat detecting a cap 4 with a 360-degree reading may indicate that thecap has a 7-inch tubing attached thereto, and detecting a cap 4 with a90-degree reading may indicate that the cap 4 has a 12-inch tubingattached thereto, while detecting a cap 4 with a 180-degree reading mayindicate that the cap 4 has an 18-inch tubing attached thereto. Otherembodiments may employ other suitable predefined relationships betweenresolution degrees and tubing length (or other characteristic of the cap4 or other components of the base/reservoir cap unit or connectedinfusion set).

Once the infusion pump device 30 detects the tubing length, the infusionpump device 30, for example, may automatically set the priming sequencefor the detected tubing length (and/or perform one or more otherpredefined tasks that depend or relate, at least in part, to thedetected tubing length). Such embodiments can further automate infusionmedia delivery (such as, but not limited to insulin delivery), thusmaking therapy easier for the user.

In particular embodiments, the sensor (element 34) includes an AMR anglesensor that is configured to detect one or more magnetic field angles.For example, the sensor (element 34) may include an AMR angle sensorhaving dual Wheatstone bridges that are offset from each other by 45°.Such embodiments may be configured to detect the angle of orientation ofthe magnet (element 42) in the cap 4 (or base/reservoir/cap unit)relative to the sensing plane of the sensor (element 34).

Referring briefly back to FIGS. 4H and 4I a magnet 42 is shown with itsNorth/South direction aligned vertically as shown in those Figures, i.e. parallel to the axis of the cap 4. Only one item of information canbe carried by the positioning of the magnet as there are only twopossible orientations. The first orientation has the north seeking poleuppermost i. e. facing outwardly with respect to the reservoir and up asshown in FIG. 4H, and the second is where the north seeking pole facesdownwardly as shown in FIG. 4I i. e. towards the reservoir. A convenientimplementation of this “upright” alignment of the magnet i. e. thealignment with the magnet parallel to the cap axis is that shown inFIGS. 4C and 4D.

If more information is to be conveyed it is proposed to mount the magnetwithin the cylindrical outer wall of the cap such that its field(North-South direction) is at an angle with respect to the axis of thecap. In other words at an angle with respect to the direction of thecylindrical wall itself such as to lie on a notional helix runningaround the wall. As there are a large number of possible angularorientations, a greater amount of information can be conveyed by theselection of the angle. This can be implemented in two possible ways.Either a bar magnet can actually be mounted at an angle within thecylindrical surface of the cap or a piece of magnetizable material canbe mounted vertically aligned within the cylindrical wall of the capsuch as shown in FIGS. 4C and 4D, and then magnetized at the desiredangle.

In the embodiment illustrated in FIGS. 4Ta to 4Td the angle of themagnetic field is sensed by an AMR angle sensor 34 placed in the pumpimmediately beside the reservoir receptacle. The amount of informationthat can be conveyed is only dependent on the resolution of the AMRangle sensor.

An example of a commercially available AMR angle sensor is the ADA 4571manufactured by Analog Devices of 1 Technology Way, P.O. Box 9106,Norwood, Mass. 02062-9106, United States of America. This device is anintegrated AMR angle sensor and signal conditioner.

An AMR angle sensor typically contains dual Wheatstone bridges that areoffset by 45° and generate a quadrature output (sine and cosine)signals. When a simple dipole bar magnet is rotated about a mid-pointbetween its north and south poles in a plane parallel to the surface ofthe chip, the chip will deliver two sinusoidal signals, one following acos (2α) and the second following a sin (2α) function, a being the anglebetween the sensor axis and the direction of the field created by thebar magnet. The active area of a single sensor gives an available angleof 180 degrees (to increase that requires an increase in the number ofsensors). Thus using an AMR angle sensor the direction of a magneticfield can be measured electrically by taking the bridge outputs andsolving for angle α. If the sine output is V_(SIN), and the cosineoutput is V_(COS), the angle α is given by the expression arctan(V_(SIN)/V_(COS))/2. By deriving the magnetization angle of the magnet,we can establish whether a specific magnet has been installed into thecap 4 (or base/reservoir/cap unit).

The drawings in FIGS. 4Ta-4V are provided to help explain certainexamples of how such angle detection can be carried out with an AMRangle sensor. However, other embodiments may employ other suitable anglesensors or AMR angle sensor configurations. For example, other sensorand magnet arrangements may be employed, where the magnetic fieldstrength is sufficient to saturate the sensor. For example, a workingfield strength of H>25 kA/m (resp. 40-50 mT) over temperature, ie a hightemperature Hall Effect sensor may be employed. However, other suitablefield strengths may be employed in other embodiments.

With reference to FIG. 4Ta, an angle α of a magnet (element 42) is shownschematically. With the sensor plane of the sensor (element 34) in theplane of the sheet of FIG. 4Ta and the magnet (element 42) arrangedwithin detectable proximity to the sensor plane, the output of thesensor (element 34) will be defined by the angle α of the magnet(element 42). An output of the sensor (element 34), relative to theangle α of a magnet (element 42) is graphically represented in FIG. 4U,where the sensor (element 34) has dual, saturated-mode Wheatstonebridges that generate quadrature (sine and cosine) signals. By selectingthe angle of the magnet (element 42) in FIG. 4Ta about the axis A, theoutput of the sensor (element 34) would lie on the sinusoid, asrepresented by the graph in FIG. 4U.

Therefore, the graph in FIG. 4U represents an example output voltage(ΔVn/Vcc) 53 of an AMR angle sensor (as element 34), based on the angleα. Accordingly, by associating the output of the AMR angle sensor (aselement 34) with the corresponding angle α, the angle β (the anglebetween an axis Y (generally parallel to the external side (“ESC”) ofthe cap 4 and/or to the centerline A of the cap 4 shown in FIGS. 1-3)and the north direction (F_(N)) of the magnetic field) of a magneticfield from a magnet (element 42) on a cap 4 (or base/reservoir/cap unit)can be determined. Furthermore, by associating each angle β with apredefined characteristic of the cap 4 (or other component of thebase/reservoir/cap unit or infusion set connected thereto), the outputof the AMR angle sensor (element 34) can be associated with suchpredefined characteristic. In this manner, the output of the AMR anglesensor (element 34) can be used to detect a particular characteristic ofthe cap 4 (or other component of the base/reservoir/cap unit or infusionset connected thereto).

In particular embodiments, such angle sensors can be employed to providepresence detection, magnet angle detection (e.g., associated withpredefined characteristics), or both. For example, using an AMR anglesensor or other suitable angle sensor (as element 34), the presence of acap 4 (or base/reservoir/cap unit) can be detected by providing a magnetof sufficient strength and direction to drive the bridge circuit outputof the sensor (element 34) to within a predefined zone, when the cap 4(or base/reservoir/cap unit) is in a proper or fully installed positionwithin the reservoir receptacle 32 of the infusion pump device.Insufficient field strength in this arrangement would be interpreted asthe cap not fully installed. It is also understood that although FIG.4Ta shows the magnetic field angle α in an x-y plane, the magnetic fieldangle α is not limited to the x-y plane and can also be set at magneticfield angle α relative to a z axis to provide a three-dimensionalmagnetic field angle α.

Although a particular embodiment is shown in FIG. 4Ta showing the effectof an angle α, the use of an angled magnetic field at an angle αrelative to the sensor 34 is not limited to a bar magnet 42 physicallyskewed at an angle α. Rather as shown in FIGS. 4Tb-4Td, variousconfigurations and orientations of a magnet (element 42) can be used toprovide the angled magnetic field at an angle β relative to an externalside (“ESC”) of the cap 4 (β is the angle between an axis Y and thenorth direction (F_(N)) of the magnetic field, where the axis Y isgenerally parallel to the external side ESC of the cap 4 and/or to thecenterline A of the cap 4 shown in FIGS. 1-3). In particularembodiments, the magnetic field is inclined at the angle β relative tothe housing (or an external side ESC) of the cap 4, regardless of theshape of the actual magnet 42 to produce an angled magnetic field at thedesired angle β.

For instance, in non-limiting embodiments in which the magnet 42 is abar shaped magnet, the magnetic field would be inclined at an anglerelative to the sides and/or ends of the bar shape to produce thedesired magnetic field angle β relative to the external side ESC of thecap 4, regardless of the actual physical angle of the bar shaped magnet42 relative to the cap 4. Traditionally, bar magnets have a fielddirected outward of the ends of the magnet with no angular deviation.Accordingly, in particular embodiments, the magnet can be of any shape,size and/or orientation, as discussed above and below, as long as itproduces a magnetic field at the desired angle β. This can alsofacilitate manufacturing in embodiments where the material is placed inthe cap 4 and then magnetized (after placing the material in the cap) toproduce the desired magnetic field at angle β. It is noted that themagnetic field may be non-uniform or distorted, if inclined at an angleβ that does not align with the ends of said bar magnet 42 (or if anasymmetrical shaped magnet is used). However, these non-uniformities ordistortions need not be severe enough to prevent the sensor 34 fromdetecting (or correctly determining) the angle β of the magnetic fieldof the magnet 42 in the cap 4.

In particular embodiments, an angle β between 5° to 85°, 95° to 175°,185° to 265° or 275° to 355° can provide sufficient ability to detect anangled magnetic field for the magnet 42 in cap 4. If a sufficientlyaccurate sensor can be used, then the angle β can be between 2.5° to87.5°, 92.5° to 177.5°, 182.5° to 267.5° or 272.5° to 357.5° to providesufficient ability to detect an angled magnetic field for the magnet 42in cap 4. If less accurate sensors are used, the angle β can be between10° to 80°, 100° to 170°, 180° to 260° or 285° to 350° to providesufficient ability to detect an angled magnetic field for the magnet 42in cap 4. The magnetic field may be at any angle within these ranges toprovide a sufficient angular alignment and detection of the magneticfield by the sensor 34. Use of the angled magnetic field helps avoidinterference from magnetic fields produced by magnet sources having thefields oriented in a planar direction relative to the cap 4 or that arerandomly and temporarily near the infusion pump device. It is alsounderstood that although FIGS. 4Tb-4Td show the magnetic field angle βin an x-y plane, the magnetic field angle β is not limited to the x-yplane and can also be set at magnetic field angle β relative to a z axisto provide a three-dimensional magnetic field angle β.

Although the angle β is shown in FIGS. 4Tb-4Td as it relates to theexternal side ESC of the cap 4, which is generally parallel to the anaxis Y (and/or to the centerline A of the cap 4 shown in FIGS. 1-3), itis understood that the external side ESC of the cap 4 is not limited tobeing generally parallel to axis Y (and/or to the centerline A of thecap 4 shown in FIGS. 1-3). For instance, if the external side ESC of thecap 4 is inclined in one direction (such as, but not limited to, aslight taper towards the top center of the cap or a taper inward towardthe base), the angle β can be adjusted to account for this incline toform a new angle β′ or still utilized as angle β with reference to the Yaxis (and/or to the centerline A of the cap 4 shown in FIGS. 1-3).

In particular embodiments, a single magnet 42 in cap 4 is used. Furtherdifferentiation of the cap 4 may be done by selecting and usingdifferent magnets each with magnetic fields at different angles β toallow detection of different characteristics as further described below.However, in other embodiments, additional magnets (e.g., 2, 3, 4, 5 ormore magnets) may be included in the cap 4, each with their own magneticfield set at a selected angle β. The magnets would then be detected,sequentially, as the cap 4 is rotated into the housing of the infusionpump device to provide a magnetic field sequence that uniquelyidentifies a characteristic, infusion set or other characteristic of thecap 4 (or base/reservoir/cap unit or associated infusion set).

While any suitable number of predefined zones may be employed, dependingupon the sensitivity and resolution capabilities of the sensor (element34) and associated electronics, the graph in FIG. 4U shows four zones,labeled Z1, Z2, Z3 and Z4, respectively. The four zones Z1-Z4 are alsoshown in FIG. 4V, for example, by filtering the bridge outputs of thesensor (element 34) through a comparator and digitizing the output. Inzone Z1 of FIGS. 4U and 4V, V sin>0 and V cos>0 (which can be associatedwith a digital value [1,1]). In zone Z2 of FIGS. 4U and 4V, V sin>0 andV cos<0 (which can be associated with a digital value [1,0]). In zone Z3of FIGS. 4U and 4V, V sin<0 and V cos<0 (which can be associated with adigital value [0,0]). In zone Z4 of FIGS. 4U and 4V, V sin<0 and V cos<0(which can be associated with a digital value [0,1]).

While resolution of 4 states is shown in FIGS. 4U and 4V, otherembodiments may be configured to detect IN position or OUT position(with the reservoir not fully installed in the infusion pump) states asdescribed above, 3 states, 4 states or more than 4 states, bycompartmentalizing the analog output into larger (or smaller) zones. Forexample, four different IN position states (in addition to the OUTposition state 57) can be associated with the four zones Z1, Z2, Z3 andZ4, to detect in positions at 55, 61, 63 and 65, respectively, dependingupon the angle of the magnet (element 42). Thus, a magnet (element 42)having a first magnetic field angle α1 may provide a detectable signalassociated with the IN position 55, when the cap 4 (orbase/reservoir/cap unit) carrying that magnet (element 42) is in aproper or fully installed position within the reservoir receptacle 32 ofthe infusion pump device. Similarly, another magnet (element 42) havinga second magnetic field angle α2 may provide a detectable signalassociated with the IN position 61, when the cap 4 (orbase/reservoir/cap unit) carrying that magnet (element 42) is in aproper or fully installed position within the reservoir receptacle 32 ofthe infusion pump device. Similarly, another magnet (element 42) havinga third magnetic field angle α3 may provide a detectable signalassociated with the IN position 63, when the cap 4 (orbase/reservoir/cap unit) carrying that magnet (element 42) is in aproper or fully installed position within the reservoir receptacle 32 ofthe infusion pump device. Similarly, another magnet (element 42) havinga fourth magnetic field angle α4 may provide a detectable signalassociated with the IN position 65, when the cap 4 (orbase/reservoir/cap unit) carrying that magnet (element 42) is in aproper or fully installed position within the reservoir receptacle 32 ofthe infusion pump device.

By associating one of the zones with the position and angle of themagnet, when the cap 4 (or base/reservoir/cap unit) is in a proper orfully installed position within the reservoir receptacle 32 of theinfusion pump device, a detection of a sensor output in that zone can beassociated with a detection of the cap 4 (or base/reservoir/cap unit) ina proper or fully installed position within the reservoir receptacle 32.Thus, for example, where zone Z1 is associated with an IN position(e.g., a fully installed position), if the output of the sensor (element34) falls within that zone Z1, then the electronics connected orassociated with the sensor 34 determines that the cap 4 (orbase/reservoir/cap unit) is in an IN position (e.g., a fully installedposition). However, if the output of the sensor (element 34) fallswithin an OUT position (e.g., in the zone labeled 57), then theelectronics connected or associated with the sensor 34 determines thatthe cap 4 (or base/reservoir/cap unit) is in an OUT position (e.g., notfully installed position). In addition, the sensor (element 34) andelectronics connected or associated therewith can be configured toresolve external magnetic field interference, by determining theexternal magnetic field 59, if the output of the sensor (element 34)does not fall within one of the previously-discussed zones 55 and 57.

In an example embodiment, four different caps 4 (or base/reservoir/capunits) may be provided with four distinct magnetic field orientations,respectively. Thus, a single type of magnet may be used in all fourdifferent caps 4 (or base/reservoir/cap units), but with the magneticfield angle arranged in each cap at a different one of four distinctorientations to relative to each other cap (e.g., by defining whichmagnet pole faces toward the top of the set connector). This cansimplify manufacturing and reduce manufacturing costs by allowing theuse of the same type of magnet (but arranged in different respectiveorientations) in multiple different types of caps 4 (orbase/reservoir/cap units). Alternatively, the magnet may be magnetizedwith a desired field orientation, after the magnet is installed in thecap 4 (or base/reservoir/cap unit).

Accordingly, AMR angle sensors (or other angle sensors) can be employedas sensor element 34 to provide presence detection, to detect thepresence of a cap 4 (or base/reservoir/cap unit), e.g., by detecting asensor output corresponding to a predefined in position (e.g., position55). Alternatively or in addition, the AMR angle sensors (or other anglesensors) can be employed as sensor element 34 to differentiate betweendifferent types of caps 4 (or base/reservoir/cap units or infusion setsconnected thereto) by detecting and differentiating between states(e.g., positions 55, 61, 63 and 65). While the example in FIG. 4V showsfour different detectable states, other embodiments may be configured todifferentiate between less than four or more than four states.

For instance, an infusion pump system may be configured to provide adifferent sensor output for each of three potential magnetization angles(20°, 65°, and 145° with respective ranges of +/−5°), fordifferentiation of three different caps 4 (or three differentbase/reservoir/cap units or infusion sets connected thereto). It ispossible to have magnets magnetized at other angles, but it may bepreferable to overlap between the respective outputs for betterdifferentiation of different infusion sets.

In particular embodiments, anisotropic materials are used for the magnet(element 42). In other embodiments, isotropic materials may be utilized,or a combination of anisotropic and isotropic materials are used for themagnet (element 42). In particular embodiments, a magnetization processcan be the last step in the processing and fabrication of magnets.Magnetization can be accomplished in any suitable manner, such as, butnot limited to exposing the magnet to a large external magnetic field,for example by discharging a bank of capacitors, where a pulse of highenergy realigns the magnetic domains and creates a remnant magnetization(Br) in the magnet. The remnant magnetization of an isotropic materialwill have the same direction as the external field used to magnetize themagnet, while an anisotropic material can be magnetized only in itspreferred direction. This preferred direction allows anisotropicmagnets, such as sintered NdFeB, to have higher magnetic properties thanisotropic materials, such as bonded NdFeB.

In further embodiments, a magnetic strip is arranged on the cap housing5, to extend in a direction around the axis A of the cap 4, such thatdifferent locations on the magnetic strip are aligned with (or pass) thesensor (element 34) on the infusion pump device, as the cap 4 (orbase/reservoir/cap unit) is inserted into the reservoir receptacle 32 atdifferent rotational positions relative to the axis A. In suchembodiments, the rotational position of the cap 4 (or base/reservoir/capunit) can be detected, based on the particular location on the magneticstrip that is aligned with (or passes) the sensor (element 34).

In such embodiments, the sensor (element 34) or a separate dedicatedsensor (not shown) may be configured to detect installation activities(such as, but not limited to, detection of a first portion of themagnetic strip, or an activation of a designated manual operator asdescribed above). Upon detection of an installation activity, the sensor(element 34) and associated electronics are activated to poll or readcontinuously or intermittently, to seek a magnetic field or signaturefrom the magnetic strip. Upon detection (or other interaction) with themagnetic strip, the sensor element (element 34) and associatedelectronics may be configured to read information from the magneticstrip. Such information can be employed by the electronics (e.g.,electronics 60 in FIG. 5) to control or set initial or ongoingoperations of the infusion pump device 30 and/or perform other actionsas described herein. During usage of the infusion pump device 30, thesensor element (element 34) and associated electronics may monitor theposition of the cap 4 (or base/reservoir/cap unit), for example, todetermine whether the cap 4 (or base/reservoir/cap unit) dislodges orotherwise moves relative to the infusion pump device 30, duringadministration of therapy to the user. If dislodgement or an impropermovement of the cap 4 (or base/reservoir/cap unit) relative to theinfusion pump device 30 occurs during therapy, the electronics (e.g.,electronics 60 in FIG. 5) may control or stop operation of the infusionpump device 30, as appropriate. If a proper installation of the cap 4(or base/reservoir/cap unit) is subsequently detected, then theelectronics (e.g., electronics 60 in FIG. 5) may be configured to resumetreatment (e.g., resume delivery of infusion media) in accordance with apre-programmed treatment profile (e.g., infusion media delivery profile)associated with the user, or in accordance with a pre-defined defaulttreatment (delivery) program.

In particular embodiments, the housing of the infusion pump deviceincludes an auxiliary magnet (for example auxiliary magnet 67 in FIG.4E) positioned to interface with the magnet of the cap 4 (orbase/reservoir/cap unit) when it is initially inserted into thereservoir receptacle 32 of the infusion pump device 30, for example,prior to rotating the cap 4 into a locked position. The auxiliary magnetis positioned with its poles arranged relative to poles of the magnet inthe cap 4 (or base/reservoir/cap unit), to repulse the magnet in the cap4 (or base/reservoir/cap unit). In such embodiments, the auxiliarymagnet interacts with the magnet in the cap 4 (or base/reservoir/capunit) to apply a sufficiently repulsive force on the magnet in the cap 4that it can be felt, but also manually overcome by the user applying amanual twisting force on the cap 4, to affirmatively allow insertion andtwisting (rotation relative to the axis A) of the cap 4 (orbase/reservoir/cap unit) in the reservoir receptacle 32 of the infusionpump device 30. In addition, a repulsive force from the auxiliary magnetcan be provided to force a loose cap 4 (or base/reservoir/cap unit)outward (linearly relative to the axis A), so that it is apparent to theuser that the loose cap 4 (or base/reservoir/cap unit) is not properlyinstalled within the reservoir receptacle 32 of the infusion pump device30.

In some embodiments, the auxiliary magnet is located on the infusionpump device 30, beneath the cap 4 (or base/reservoir/cap unit), insufficient alignment and proximity to with the magnet on the cap 4 (orbase/reservoir/cap unit) when the cap 4 (or base/reservoir/cap unit) isfirst inserted into the reservoir receptacle 32 to provide the repulsiveaction. In this case, the field of the auxiliary magnet is aligned tocause repulsion and may be angled to match with the field of the magnetin the cap 4 (or base/reservoir/cap unit). In other embodiments, theauxiliary magnet is mounted in the side of the housing 33 of theinfusion pump device 30, in the region of the receptacle 32, with thefield of the auxiliary magnet aligned to provide a repulsive force in adirection that tends to push the cap 4 (or base/reservoir/cap unit)outward from the reservoir receptacle 32 (linearly relative to the axisA).

In still other embodiments, the auxiliary magnet is placed adjacent oralong the rotational path that the magnet in the cap 4 (orbase/reservoir/cap unit) will follow as it is rotated during aninstallation process for installing the cap 4 (or base/reservoir/capunit) in the reservoir receptacle 32. In further examples of suchembodiments, a catch or stop surface formed by a lip and/or slot cutinto the threads is provided such that the repulsion between the magnetsmust be overcome to move the cap 4 away from the catch or stop surface,such as out of the slot beneath the lip. In such embodiments, themagnets may be used to help avoid unthreading of the cap 4 from thehousing 33 of the infusion pump device 30, unless sufficient userintervention (manual force) is applied to overcome the repulsive force.

In particular embodiments, the auxiliary magnet is magnetized afterbeing placed in the housing to orient the field to provide theappropriate, desired repulsive force. In some embodiments, the pole isaligned at an angle to reduce the repulsive effect or to align it withthe magnetic field of the magnet in the cap 4 (or base/reservoir/capunit) to maximize the repulsive force.

In further embodiments, the auxiliary magnet is configured to attractthe magnet in the cap 4 (or base/reservoir/cap unit) and help hold themagnet in the cap 4 (or base/reservoir/cap unit) in place, when the cap4 (or base/reservoir/cap unit) is arranged in a desired positionrelative to the reservoir receptacle 32. In further embodiments in whichmagnetic attraction is employed, a non-magnetized component made fromferric material that will interact magnetically with the magnet in thecap may be employed instead of or in addition to the auxiliary magnet.For example, one or more non-magnetized, magnetically interactiveelement can be placed at one or more strategic locations along therotational path of the cap 4, to help move the cap 4 to or retain thecap 4 (or base/reservoir/cap unit) in one or more predefined positions.

In some embodiments, the auxiliary magnet is formed or provided as aflat piece of material, and may come in a variety of shapes, such as butnot limited to, round, square, triangular or the like. In particularembodiments, the auxiliary magnet is in the shape of a sphere thatallows the material of the auxiliary magnet to be placed in anyorientation desired during manufacturing. In such embodiments, themagnetic field may be induced, after assembly. In other embodiments, theauxiliary magnet is magnetized prior to being mounted to the infusionpump device 30. In particular embodiments, the auxiliary magnet has acurved shape that matches or fits the curved shape of the cap (orbase/reservoir/cap unit). In particular embodiments, the auxiliarymagnet is formed in a suitable size and shape to be accommodated in thehousing 33 of the infusion pump device 30, and provide a magnetic fieldof desired size and strength.

In particular embodiments, the auxiliary magnet is placed in positionsthat minimize interference with a sensor 34 provided to detect thepresence of the magnet 42 in the cap 4 (or base/reservoir/cap unit). Forinstance, the sensor may be on the opposite side of the reservoirreceptacle 32 (diametrically opposite side, relative to the axis A),with respect to the location of the auxiliary magnet. In otherembodiments, the sensor 34 may be arranged at any other suitablelocation in the housing 33 of the infusion pump device 30, where thefield of the auxiliary magnet does not provide a detectable reading onthe sensor 34. In other embodiments, the auxiliary magnet is placed atany suitable location, even if it is detectable by the sensor 34, andthe sensor 34 is calibrated to account for the presence of the auxiliarymagnet. In such embodiments, the sensor 34 may be configured to measurea difference in the magnetic field as the magnet 42 in the cap 4 (orbase/reservoir/cap unit) moves into a properly installed position (orother predefined position) relative to the sensor 34.

In particular embodiments, electronics 60 associated with the sensorelement(s) are configured to determine the position of the cap 4, basedon the particular parameters detected by the sensor element(s). Ageneralized diagram of example electronics 60 associated with a sensorelement 34 is shown in FIG. 5. The electronics 60 in FIG. 5 includeprocessing electronics 62 connected to receive electronic signals fromthe sensor, through a communication link 64. In one embodiment, thecommunication link 64 comprises one or more electrically conductivewires or traces or other electrically conductive material, wirelessconnection (such as, but not limited to radio frequency RF, Bluetooth,WiFi, inductive coupling, or other wireless communication link), or acombination thereof.

In particular embodiments, the processing electronics 62 includes one ormore electronic processors configured to process information receivedfrom the sensor element 34. Such electronic processors may include, butare not limited to, a programmable general purpose processor,microprocessor, programmed or hardware configured special purposeprocessor, or the like, that is programmed with software, hardware,firmware, combinations thereof or otherwise configured to performoperations described herein. The electronics 60 includes one or moreelectronic memory devices 66 that stores data, programs or othersoftware employed by the processing electronics 62 to perform operationsdescribed herein. In particular embodiments, the electronics 60 alsoincludes a receiver, transmitter or transceiver 68, configured toreceive, transmit, or both receive and transmit information from or to afurther electronic device (not shown), such as, but not limited to, auser's computer, a health care entity's computer, or the like. Theelectronics 60 also includes or is connected with one or more powersources (not shown) for providing electrical power to the processingelectronics 62 and, as needed, to the memory 66 and transceiver 68. Inparticular embodiments in which the sensor element 34 requireselectrical power, the above-noted power source(s) or a separate powersource associated with the sensor element provides electrical power tothe sensor element, for example, through the link 64 or through aseparate electrical connection (not shown).

The processing electronics 62 is programmed or otherwise configured toprocess information received from the sensor element 34 and determinethe presence or position of the cap 4 relative to the reservoirreceptacle 32 of the infusion pump device 30 or other parameter of thecap 4 (or base/reservoir cap unit), based on the particular parametersdetected by the sensor element(s). In one example embodiment, theprocessing electronics 62 is configured to detect the presence orabsence of a signal from the sensor element 34, to determine thepresence or absence of the cap 4 in a predefined position relative tothe reservoir receptacle 32. In other embodiments, the processingelectronics 62 is configured to process a signal from the sensor element34 to determine one or more parameters associated with the position ofthe cap 4, such as, but not limited to, the amount of rotation or lineardisplacement of the cap 4 relative to the reservoir receptacle 32, arotational position of the cap 4 around the axis A, a linear position ofthe cap 4 along the dimension of the axis A, an angular position of theaxis A of the cap 4 relative to the axis A of the reservoir receptacle32, or any combination thereof. In yet other embodiments, the processingelectronics 62 is configured to process a signal from the sensor element34 to determine one or more other parameters associated with acharacteristic of the cap 4 (or base/reservoir/cap unit).

In particular embodiments, the electronics 60 are attached to orcontained within a housing 33 of the infusion pump device 30. In otherembodiments (such as embodiments in which the element 42 includes asensor device), the electronics 60 are attached to or contained withinthe cap 4. In yet other embodiments, some of the components of theelectronics 60 are attached to or contained within the housing 33 of theinfusion pump device 30, while other components of the electronics 60are attached to or contained within the cap 4. For example, in oneembodiment, one or both of the processing electronics 62 and transceiver68 are on or in the infusion pump device 30, while some or all of thememory 66 is on or in the cap 4.

In embodiments described above, magnet elements and sensor elements arearranged on the cap 4 and the infusion pump device 30, for detecting theposition of the cap 4 relative to the infusion pump device 30 (e.g., fordetecting a proper connection of the cap 4 or the base/reservoir/capunit with the infusion pump device 30). In other embodiments, one ormore magnet and sensor elements as described above are employed todetect one or more other characteristics associated with the cap 4 orthe base/reservoir/cap unit, infusions set 50 (or combinations orcomponents thereof), in addition to or as an alternative to detectingpresence in or proper connection with the infusion pump device 30. Invarious embodiments, such other characteristics include but are notlimited to characteristics of the cap 4, reservoir 1 (or its contents),infusion set 50, connection interface 40, or any combination thereof.

In those embodiments, a particular characteristic may be associated withone or more detectable parameters, where the detectable parametersinclude, but are not limited to one or more of: the existence of one ormore magnet or sensor elements on the cap 4, the pattern or location ofone or more magnet or sensor elements on the cap 4 (circumferential orlinearly location relative to the dimension of the axis A), the type ofmagnet or sensor element on the cap 4, the polarity, magnetic fieldangle β or field strength of the magnet, or the like. In particularembodiments, the detectable parameters provide a detectable signatureassociated with the cap 4 (or the infusion pump device 30), where suchsignature can be unique to the cap 4 with respect to other caps, or maybe non-unique with respect to signatures of other caps.

Accordingly, in particular embodiments, each different characteristic ofthe reservoir 1, infusion set 50 or connection interface 40, isassociated with a respectively different detectable parameter (forexample, location or type) of the magnet or sensor element. By readingthe signature of the cap (or infusion pump device 30), the parametersthat define the signature are detected. In those embodiments, theprocessing electronics 62 is configured to detect one or more detectableparameters of the magnet or sensor element; then determine one or morecharacteristics of the cap, base/reservoir/cap unit, reservoir, orinfusion set based on the detectable parameter(s); and conduct one ormore further predefined actions based on or using the determinedcharacteristic(s).

In particular embodiments, the electronic circuit 60 and processingelectronics 62 in FIG. 5 is configured to perform a process 150, such asexplained with reference to the flowchart in FIG. 6. For example, in theprocess 150, a plurality of predefined parameters (parameters that couldpotentially be detected) are associated on a one-to-one basis (or otherpredefined association) with a corresponding plurality ofcharacteristics of the cap 4, base/reservoir/cap unit, reservoir 1 orits contents, infusion set 50, connection interface 40, or anycomponents or combination thereof. At 152, the associations ofdetectable parameters and the plurality of characteristics is stored ina memory, such as memory 66.

At 154 in the process 150, one or more parameters of one or moredetectable elements 42 are detected by one or more sensor elements 34,for example, during or upon installation (or attempted installation) ofa cap 4 or base/reservoir/cap unit in the infusion pump device 30. At156, the processing electronics 62 compares information received fromthe sensor element(s) 34 with one or more pre-defined stored thresholdvalues, or with information stored in a table (or stored in another dataarrangement that associates a plurality of different detectable magnetlocations or other magnet parameters with a corresponding plurality ofcharacteristics, for example, but not limited to, a one-to-onecorrespondence of each different magnet location with a differentcharacteristic, respectively). Alternatively or in addition, theprocessing electronics 62 may be configured to compare informationreceived from the sensor element 34 with one or more thresholds or withinformation stored in a table or in another data arrangement thatassociates a plurality of different types of magnets (such as, but notlimited to, magnets having different polarities, magnetic field angle β,field strength, or a combination of the preceding) with a correspondingplurality of characteristics (for example, but not limited to, aone-to-one correspondence of each different magnet type with a differentcharacteristic, respectively). In those embodiments, the processingelectronics 62 is configured to determine the magnet location, themagnet type or both, based on one or more comparisons of informationreceived from the sensor element 34 with the stored information. Inparticular embodiments, the stored table or other data arrangement isstored in the electronic memory 66.

Examples characteristics of the reservoir 1 (or its contents) include,but are not limited to, one or more of: the type or identity of themanufacturer of the reservoir 1 or components or contents thereof, thesize of the reservoir 1, the type of infusion media in the reservoir 1(such as, but not limited to the type of insulin, other drug or othermedia), the concentration of the infusion media in the reservoir 1, thevolume amount of infusion media in the reservoir 1, a date (such as, butnot limited to a date corresponding to an expiration date, fill date orother date related to the infusion media in the reservoir 1 or thereservoir 1 itself), a location (such as, but not limited to a locationcorresponding to the place where the reservoir 1, the cap 4, or infusionmedia in the reservoir 1 (or all) was made, filled, or otherwiseprocessed, or a location for authorized use of the reservoir 1), a lotnumber (or other code associated with the batch in which the reservoir 1or infusion media was made, cleaned, filled or otherwise processed), aserial number, a unique ID, a manufacture date, user identificationinformation (for authorized users of the reservoir 1), or otherpredefined characteristic.

Example characteristics relating to the infusion set 50 connected to thecap 4 include, but are not limited to one or more of: the type ormanufacturer of the infusion set 50 or components thereof, the length ofthe tubing 52, the diameter of the tubing 52, the length of the needleor cannula 56, the diameter of the needle or cannula 56, a date (suchas, but not limited to a date corresponding to an expiration date,manufacturing date or assembly date of the needle or cannula 56), alocation (such as, but not limited to a location corresponding to theplace where the needle or cannula 56 was made or assembled with thehousing 54, or a location for authorized use of the infusion set orcomponents thereof), a lot number (or other code associated with thebatch in which the infusion set 50 or components thereof was made,cleaned or otherwise processed), a cannula type, a needle type, a lotnumber, a serial number, a unique ID, user identification information(for authorized users of the infusion set 50), or other predefinedcharacteristic.

Example characteristics relating to the connection interface 40 include,but are not limited to one or more of the type or manufacturer of theconnection interface 40, cap 4, base 2 or components thereof, thelength, diameter or other size dimension of the cap 4, a date (such as,but not limited to a date corresponding to an expiration date,manufacturing date or assembly date of the cap 4 or base 2), a location(such as, but not limited to a location corresponding to the place wherethe cap 4 or base 2 was made or assembled, or a location for authorizeduse of the cap 4 or base 2), a lot number (or other code associated withthe batch in which the cap 4 or base 2 was made, cleaned or otherwiseprocessed), a serial number, a unique ID, user identificationinformation (for authorized users of the infusion set 50), or otherpredefined characteristic.

In particular embodiments, the processing electronics 62 is furtherconfigured to conduct one or more predefined actions at 160 in theprocess 150, based on or using the characteristics determined at 158 inthe process 150. One or more predefined actions may include, but is notlimited to determining one or more operational settings for the infusionpump device 30, based on one or more of the characteristics determinedfrom detected parameters of the signals from the sensor element 34. Infurther examples of such embodiments, the processing electronics 62 alsoprovides signals to the drive device or other components of the infusionpump device 30, to control operations of the drive device (or othercomponents) based on one or more characteristics determined from thedetected parameters. In one example, based at least in part on thedetected parameter, the processing electronics 62 determines and setsoperational settings for one or more of: pumping rate (amount of fluidpumped per unit time), pumping time period (amount of time of pumping),pumping power (amount of fluid pressure), priming (filling) the infusionset tubing 52, priming (filling) the infusion set needle or cannula 56,detecting an occlusion in the fluid path from the reservoir 1 to theinfusion set needle or cannula 56, handling an occlusion (pumping time,pressure, or program for dislodging, compensating for, or otherwisehandling an occlusion).

Thus, in one example, the locations or types (or both) of the magnetscorrespond to one or more characteristics relating to the particulartype or size of infusion set 50 connected to the cap 4, where thedetected characteristics are employed by the processing electronics 62to determine a pumping rate or pumping time period (or both) that issufficient to prime (fill) the infusion set tubing 52, or the needle orcannula 56 (or both). In another example, the locations or types (orboth) of the magnets correspond to one or more characteristics relatingto the pumping time, pumping pressure or pumping program that issufficient to dislodge or compensate for an occlusion in that particulartype or size of infusion set 50.

In further embodiments, the processing electronics 62 is configured toperform (at 160 in the process 150) one or more other predefined actionsbased on or using the characteristic(s) determined at 158. Such otherpredefined actions may include, but are not limited to providing acontrol signal to deactivate or inhibit activation of a pump drivedevice in the infusion pump device 30, when the signal received from thesensor member 34 represents that the cap 4 or the base/reservoir/capunit is not fully or properly received within the reservoir receptacle32 of the infusion pump device 30. Alternatively or in addition, theprocessing electronics 62 is configured to provide a control signal toactivate or allow activation of a pump drive device in the infusion pumpdevice 30, when the signal received from the sensor member 34 representsthat the cap 4 or the base/reservoir/cap unit is fully or properlyreceived within the reservoir receptacle 32 of the infusion pump device30.

Alternatively or in addition, the processing electronics 62 isconfigured to perform (at 160 in the process 150) yet one or more otherpredefined actions, such as, but not limited to providing an alarmsignal, to activate an alarm indicator, when the signal received fromthe sensor member 34 represents that the cap 4 or the base/reservoir/capunit is not fully or properly received within the reservoir receptacle32 of the infusion pump device 30. In particular embodiments, theprocessing electronics 62 is configured to provide such an alarm orcontrol signal (or both), only when the processing electronics 62detects that the cap 4 or base/reservoir/cap unit is not fully andproperly received within the reservoir receptacle 32, after havingpreviously detected that the cap 4 or base/reservoir/cap unit is fullyand properly received within the reservoir receptacle 32 (for example,indicating that a previously properly received cap 4 has since beenmoved or otherwise dislodged out of that position within the reservoirreceptacle 32). In such embodiments, the processing electronics 62 mayinclude (or be connected for communication with) a display device fordisplaying an alarm condition.

The alarm display device may include any suitable indicator such as, butis not limited to one or more of: a light emitting device, LED, LCD orother visual display device; a sound emitting device, speaker, buzzer orother audio display device; a vibrator, heater, or other tactile displaydevice, or the like. In particular embodiments, the alarm display deviceis attached to or contained in the infusion pump device 30. In otherembodiments, the alarm display device is attached to or contained in thecap 4. In yet other embodiments, the alarm display device is in anexternal device (such as, but not limited to a computer, smart phone,pager, or other electronic communication device) connected forcommunication with the electronics 60, for example, through a wired orwireless communication link.

In further embodiments, the processing electronics 62 is configured toperform (at 160 in process 150) other actions, such as, but not limitedto recording data representing detected states or conditions (orcharacteristics) of one or more of the cap 4, base/reservoir/cap unit,and infusion pump device 30. In particular embodiments, the processingelectronics 62 records such data in the electronic memory 66, in a formthat can be retrieved by the processing electronics 62 or otherprocessing electronics (not shown) at a time or date after recording. Insuch embodiments, the processing electronics 62 or other processingelectronics may employ such data to generate reports, tables or otherdata structures for assisting with the evaluation of the recorded data.In yet further embodiments, the processing electronics 62 is configuredto send such recorded data, reports, tables or other data structures toa predefined entity, for example, but not limited to, by transmittingthe information through the transceiver 68. For example, in particularembodiments, the electronics 60 is configured to transmit recordedinformation to a remote facility at predefined or periodic intervals orupon receipt of such information from a sensor element.

In yet further embodiments, at 160 in process 150, the processingelectronics 62 is further configured to determine operational settingsfor the infusion pump device 30, record data or perform other predefinedtasks, based on one or more signals obtained from one or more additionalsensors (not shown), from receiver or transceiver 68, from user input(through a user interface, not shown, connected to the electronics 60),or a combination thereof. In particular embodiments, the receiver ortransceiver 68 includes a geographic positioning system receiver (suchas, but not limited to a GPS or other satellite positioning systemreceiver) that receives or determines the geographic location of theinfusion pump device 30, cap 4, or base/reservoir/cap unit.Alternatively or in addition, the processing electronics 62 is furtherconfigured to determine operational settings for the infusion pumpdevice 30, record data or perform other predefined tasks as describedbelow, based on one or more signals obtained from one or more electronicclocks or other timing devices (not shown) connected with theelectronics 60.

In examples of such embodiments, the processing electronics 62 isconfigured to detect, record (or both) the geographic location of theinfusion pump device 30, cap 4, or base/reservoir/cap unit, or the timeor date (or any combination of location, time and date), when aparticular parameter or event is detected. In one example, theparticular parameter or event is one or more of: the receipt of a signalfrom the sensor element 34 indicating that the cap 4 orbase/reservoir/cap unit has been properly and fully received within thereservoir receptacle 32; the receipt of a signal from the sensor element34 indicating that the cap 4 or base/reservoir/cap unit has not beenproperly and fully received or has been moved or dislodged from itsproper position within the reservoir receptacle 32; the receipt of asignal from the sensor element 34 indicating that the cap 4 orbase/reservoir/cap unit has been (or not been) at one or more predefinedpositions within the reservoir receptacle 32, the receipt of a signalfrom the sensor element 34 indicating that a particular type of cap 4,infusion set 50 or reservoir 1 has been received in the reservoirreceptacle 32; the movement or presence of the infusion pump device 30,cap 4, or base/reservoir/cap unit in a predefined geographic location orregion; and the like. In such embodiments, the processing electronics 62may record data representing the location or time (or both) at which anyone or more predefined events occurs, such as, but not limited to theevents described above. Alternatively or in addition, the processingelectronics 62 may record data representing one or more detectedparameters (or associated characteristics) as described above andlocations or times (or both) at which any one or more of such parameters(or associated characteristics) are detected.

In further embodiments, the electronics 60 includes one or more furthersensors (not shown) for detecting external or environmental magneticfields. In such embodiments, the processing electronics 62 is configuredto analyze information from the one or more sensors and provide awarning/alarm or provide control signals for adjusting operation of theinfusion pump device 30 (or both), based on the detected external orenvironmental magnetic field. For example, the processing electronics 62may adjust detection or processing parameters to compensate for theexternal or environmental magnetic fields, to minimize any effect of theexternal or environmental magnetic field on the detection of the magnetelement(s) 34. Alternatively or in addition, the cap 4 is configured tominimize influence by external or environmental magnetic fields, wheresuch cap configurations may include, but are not limited to, magneticfield shielding material.

In particular embodiments described above, the processing electronics 62is configured to determine operational settings for the infusion pumpdevice 30, provide alarm or control signals, record data or performother predefined tasks base, at least in part, on detection of one ormore detectable element(s) 12 (or information provided by a detectableparameter of the detectable elements(s) 42). In certain embodiments, theprocessing electronics 62 is configured to authenticate abase/reservoir/cap unit, cap 4 or reservoir 1, based on one or more ofthe parameters detected from the signals received from the sensorelement 34. For example, the processing electronics 62 determineswhether or not the detected parameters correspond to predefinedcharacteristics associated with an authentic base/reservoir/cap unit,cap 4 or reservoir 1. In such embodiments, an authenticbase/reservoir/cap unit, cap 4 or reservoir 1 may be for example, onethat is authorized for use with the infusion pump device 30 by themanufacturer of at least one of the infusion pump device thebase/reservoir/cap unit, cap 4, or reservoir 1. Alternatively or inaddition, an authentic base/reservoir/cap unit, cap 4 or reservoir 1 maybe one that is authorized by another predefined entity, such as, but notlimited to, a government or industry standards or regulatory entity, orother predefined entity.

In certain embodiments, the processing electronics 62 coupled to thetransceiver 68 may access, e.g., via a wired or wireless connection,directly or via another device(s), a database (e.g., on the Internet) toverify the authenticity of one or more of the base, reservoir, and/orcap using the serial number (unique ID, etc.) obtained from the base,reservoir, and/or cap, respectively, to confirm that such unit isauthentic and genuine. Medical devices are stringently tested andheavily regulated, and use of unauthorized components may jeopardizeproper treatment of the patient. Many of the components, such as thebase/reservoir/cap, infusion set, etc., are single-use components, andthe processing electronics 62 on the infusion pump device 30, e.g., maykeep track of the serial numbers such that the patient is prohibitedfrom re-using, purposefully or accidentally, a component where its safeuseful life has already been depleted. Moreover, along with verifyingauthenticity, lot numbers, e.g., for the respective base, reservoir,and/or cap also may be checked against the database to ensure that norecalls are outstanding, and the user is alerted by (or even prohibitedby) the infusion pump device 30 (or any other suitable device) to notuse a particular base, reservoir, and/or cap and return it to themanufacturer if there is a recall underway, further enhancing the safetyof the patient by using the most currently available information.

In particular embodiments, a detected geographic location, time or date(or any combination thereof) is included in the determination ofauthenticity. For example, the processing electronics 62 may beconfigured to determine that a base/reservoir/cap unit, cap 4 orreservoir 1 installed in the infusion pump device 30 is authentic, whenthe parameters detected from the signals received from the sensorelement 34 correspond to characteristics that have been predefined (forexample, pre-stored in memory 66) as an authentic base/reservoir/capunit, cap or reservoir for use at a particular time, date or geographiclocation (or a combination thereof). In such embodiments, the memory 66may store a table or other suitable data configuration that associatescombinations of detectable magnet parameters and one or more dates,times and geographic locations (or any combination thereof) with anauthentication determination.

Table 1 shows an example of an association of detectable parameters(labeled Parameters 1-N in Table 1) with different geographic locations(labeled Regions A-C).

TABLE 1 Parameters 1 Region A Parameters 2 Region A and Region BParameters 3 Region C . . . Parameters N Region A, Region B and Region C

In Table 1, a base/reservoir/cap unit, cap 4 or reservoir 1 that has adetectable magnet parameter corresponding to Parameter 1 is authentic,when the electronics 60 determines that the infusion pump device 30 isin Region A (but not when the electronics 60 determines that theinfusion pump device 30 is in any other region). Also in Table 1, adetectable magnet parameter corresponding to Parameter 2 would indicateauthenticity, when the electronics 60 determines that the infusion pumpdevice 30 is in Region A or in Region B (but not when the electronics 60determines that the infusion pump device 30 is in any other region).Similarly, in Table 1, a detectable magnet parameter corresponding toParameter 3 would indicate authenticity, when the electronics 60determines that the infusion pump device 30 is in Region C (but not whenthe electronics 60 determines that the infusion pump device 30 is in anyother region). Further in Table 1, a detectable magnet parametercorresponding to Parameter N would indicate authenticity, when theelectronics 60 determines that the infusion pump device 30 is in any ofRegions A, B or C.

Table 2 shows a similar example, but of an association of detectablemagnet parameters (labeled Parameters 1-N in Table 1) with differentgeographic locations (labeled Regions A-C) and dates (shown in years).

TABLE 2 Parameter 1 Region A 2010-2020 Parameter 2 Region A and Region B2010-2015 Parameter 3 Region C 2012-2020 . . . Parameter N Region A,Region B and Region C X

In Table 2, a base/reservoir/cap unit, cap 4 or reservoir 1 that has adetectable magnet parameter corresponding to Parameter 1 is authentic,when the electronics 60 determines that the infusion pump device 30 isin Region A and also determines that the current date is within theyears 2010 and 2020 (but not when the electronics 60 determines that theinfusion pump device 30 is in any other region or that the date isoutside of that date range). Also in Table 2, a detectable magnetparameter corresponding to Parameter 2 would indicate authenticity, whenthe electronics 60 determines that the infusion pump device 30 is inRegion A or in Region B and also determines that the current date iswithin the years 2010 and 2015 (but not when the electronics 60determines that the infusion pump device 30 is in any other region orthat the date is outside of that date range). Similarly, in Table 2, adetectable magnet parameter corresponding to Parameter 3 would indicateauthenticity, when the electronics 60 determines that the infusion pumpdevice 30 is in Region C and also determines that the current date iswithin the years 2012 and 2020 (but not when the electronics 60determines that the infusion pump device 30 is in any other region orthat the date is outside of that date range). Further in Table 2, adetectable magnet parameter corresponding to Parameter N has no daterestriction (as indicated by the X in Table 2) and would indicateauthenticity, when the electronics 60 determines that the infusion pumpdevice 30 is in any of Regions A, B or C.

While Tables 1 and 2 refer to Parameters 1-N (where N may be anysuitable integer), other embodiments may employ a single detectableparameter or set of detectable parameters (e.g., Characteristic 1).Also, while Table's 1 and 2 refer to Regions 1, 2, 3 and N, otherembodiments may employ any suitable number of predefined regions,including a single region. While the dates in Table 2 are represented inyears, other embodiments may employ dates corresponding to days, weeks,months, or other suitable segments. In yet further embodiments, insteadof or in addition to dates, a table (or other data configurationemployed by the processing electronics 62) includes time datacorresponding to separate ranges of time (similar to the separate dateranges shown in Table 2).

In particular embodiments, the electronics 60 is configured to allowoperation of the infusion pump device 30 when the processing electronics62 determines that the base/reservoir/cap unit, cap 4 or reservoir 1 isauthentic, and to not allow infusion operation of the infusion pumpdevice 30 when the processing electronics 62 does not determine that thebase/reservoir/cap unit, cap 4 or reservoir 1 is authentic. For example,the processing electronics 62 may be configured to provide a controlsignal to the drive device to stop operation of the drive device, orinhibit sending a drive or power signal to the drive device, or performanother predefined action to not allow dispensing of infusion media fromthe infusion pump device 30. In other embodiments, the electronics 60 isconfigured to allow an infusion operation (or a limited or otherpredefined infusion operation) of the infusion pump device 30, but toalso performs one or more further predefined actions when the processingelectronics 62 does not determine that the base/reservoir/cap unit, cap4 or reservoir 1 is authentic. Such other predefined actions include,but are not limited to, one or more of providing a readable message on adisplay device of the infusion pump device 30, providing an alarm signalfor operating an alarm indicator on the infusion pump device 30, andrecording data associated with one or more of the infusion operation,the detected characteristic(s), time, date, and geographic location, orany combination thereof.

In further embodiments, instead of associating one or more detectableparameters (e.g., Parameters 1-N in Tables 1 and 2) with geographicregion, date, time or other predefined parameter, the processingelectronics 62 is configured to employ magnetic detection by thesensor(s) 34 to determine presence or proper alignment, installation andconnection of the base/reservoir/cap unit, cap 4 or reservoir 1 in theinfusion pump device 30. Then, once proper alignment, installation orconnection of the base/reservoir/cap unit, cap 4 or reservoir 1 in theinfusion pump device 30 is detected, the processing electronics controlsoperation of the infusion pump device 30 based on whether or not theinfusion pump device 30 is determined to be within a predefined(pre-authorized) region, or is being operated within a predefined(pre-authorized) time or date. In such embodiments, a table, list orother data configuration of predefined (pre-authorized) regions, times,dates or combinations thereof is stored in memory associated with theelectronics 60, such as electronic memory 66. The processing electronics62 may be configured, in further embodiments, to determine thegeographic location, time, date (or any combination thereof) atpredefined times, periodically, randomly or the like, once the infusionpump device 30 has started operation.

In any of the above or further embodiments, the processing electronics62 may be configured to record information regarding the infusion pumpdevice 30, base/reservoir/cap unit, cap 4 or reservoir 1, or the usageand operation thereof. In particular embodiments, the processingelectronics 62 is configured to record, for example, in the memory 66data corresponding to one or more of identification informationassociated with the base/reservoir/cap unit, cap 4 or reservoir 1, datesor times of connection, operation or disconnection of thebase/reservoir/cap unit, cap 4 or reservoir 1 to the infusion pumpdevice 30, dates or times of alarm conditions, dates or times ofoperation of the infusion pump device 30, detected parameters orconditions associated with detected parameters. In further embodiments,the geographic location of the infusion pump device at the time of anyof the above recording events is recorded as an alternative to or inaddition to recording of date or time information. In such embodiments,recordings of usage of an infusion pump device 30, base/reservoir/capunit, cap 4 or reservoir 1 outside of a predefined geographic region,date or time (for example, beyond a predefined expiration date) may bemade. In further embodiments, as an alternative to or in addition torecording the event, the processing electronics 62 is configured toprovide one or more of an alarm indication and a display of a warningmessage on a display device in the infusion pump device, upon thedetection of usage of an infusion pump device 30, base/reservoir/capunit, cap 4 or reservoir 1 outside of a predefined geographic region,date or time.

In further embodiments, one or more wireless or wired communicationdevices is provided on the infusion pump device 30 (or other deliverydevice) and is configured and controlled to transmit volume informationrelating to the volume of infusion fluid remaining in or dispensed fromthe reservoir 1 (or other information corresponding to detectedparameters or associated characteristics) for display on anotherelectronic device separate from or located remote from the infusion pumpdevice 30. In particular embodiments, the wireless communicationdevice(s) are configured to connect for communication on a communicationnetwork (such as, but not limited to the Internet), with one or morepre-defined network connected devices. Such one or more pre-definednetwork connected devices may be located at remote geographic locationsrelative to the infusion pump device 30 (or other delivery device). Inparticular embodiments, such network connected devices include a serverconfigured to receive information from the infusion pump device 30 (orother delivery device) or from another network connected device (such asa cradle, user computer, or the like) that communicates with theinfusion pump device 30 (or other delivery device). Such information mayinclude, but is not limited to information corresponding to one or moredetected parameters or one or more associated characteristics, or otherinformation regarding the reservoir 1, cap 4, base/reservoir/cap unit orinfusion set as described above.

In such embodiments, the network connected server may be associated withan entity that records information, supplies associated products such asrefills or replacement parts, provides medical treatment or medicalinsurance to the user or the like. In one example, the network connectedserver is associated with the Carelink™ system of Medtronic Inc. Inother embodiments, the network connected server is one or more otherservers and associated entities. Accordingly, such information may beemployed by the server (or associated entity) to determine whether ornot (or when) to send refills, new or replacement reservoirs, caps,infusion set needle housings, infusion set tubing, or other componentsof the cap 4, base/reservoir/cap unit, or infusion set. In furtherembodiments, such information may be provided to the user's doctor orother medical treatment entity associated with the user (for tracking,diagnosing, adjusting treatment plans or other suitable uses). Thus, insuch embodiments, refills or replacement components may be sent tousers, automatically (without requiring the user to place an order), andusage information can be provided to the user's healthcare provider,insurance provider or other suitable entities, automatically.

In further embodiments, the network connected server is configured toprovide (and the infusion pump device 30 or other delivery device isconfigured to receive) information through the above-noted networkcommunication connection or other network connection. Such informationmay include, but is not limited to, instructions or recommendations forreplacing or refilling a reservoir 1, cap 4, base/reservoir/cap unit orinfusion set, messages or notices from healthcare providers, insurancecarriers or manufacturers, recall notices or the like. In particularembodiments, electronics (such as electronics 60) in the infusion pumpdevice 30 (or other delivery device) is configured to perform one ormore predefined actions (as discussed above) in response to receipt of apredefined instruction, notice or message.

In embodiments described above, one of the elements 34 and 42 includesat least one magnet, while the other of the elements 34 and 42 includesat least one sensor. In other embodiments, one of the elements 34 and 42includes both a magnet and a sensor arranged so that they do notdirectly interact, while the other of the elements 34 and 42 includes ametal or other material that is magnetizable or conducts magnetic fluxwhen in alignment or proximity (or both) with the magnet (when thebase/reservoir/cap unit is fully and properly received in the reservoirreceptacle 32 of the infusion pump device 30), but does not becomemagnetized by the magnet or conduct magnetic flux when out of alignmentor proximity with the magnet. In those embodiments, the sensor isconfigured and arranged in sufficient alignment and proximity to themetal or other material to detect the state of the metal or othermaterial being magnetized when the base/reservoir/cap unit is fully orproperly received in the reservoir receptacle 32 of the infusion pumpdevice 30.

b. Inductive Detection

In particular embodiments as described above, one (or all) of the cap 4,reservoir 1, and the infusion pump device 30 is provided with at leastone sensor, and the other (or all) of the cap 4, reservoir 1, and theinfusion pump device 30 is provided with at least one detectable featurethat is detected by the sensor when the cap 4 is properly coupled withthe infusion pump device 30. Embodiments as described above include oneor more magnetic detectable features and magnet detection sensors. Otherembodiments described herein include one or more detectable featuresthat are detected by other sensing configurations (including RF,optical, mechanical or electrical contact sensing configurations). Inother embodiments, the one or more detectable features 42 includes aninductively detectable member (or target) that can be detected by aninductive sensor, and the one or more sensor elements 34 includes aninductive sensor.

Thus, in one example, element 42 represents one or more inductivelydetectable members (or targets) carried by the cap 4, while element 34represents one or more inductive sensor elements located on the infusionpump device, in or adjacent the reservoir receptacle 32. In furtherembodiments, the relative locations of the inductive sensor element(s)and inductively detectable member(s) (target(s)) is reversed such thatthe inductively detectable member(s) 42 (or target(s)) are located inand carried by the infusion pump device 30, while the inductivesensor(s) 34 are carried by the cap 4. In yet further embodiments, theinductively detectable member(s) (or target(s)) and the inductive sensorelement(s) are each located in and carried by the infusion pump device30.

Arrangements and configurations of magnetic sensors and magneticdetectable features (as the sensors and detectable features 34 and 42)described above and shown in FIGS. 1-6 are incorporated herein byreference to apply to embodiments employing inductively detectablefeatures and inductive sensors, as the sensors and detectable features34 and 42. Thus, in particular embodiments, inductively detectabletargets and inductive sensors are employed in place of magneticdetectable features and magnetic sensors in the above-describedembodiments. In addition and where applicable, further arrangements andconfigurations described with respect to RF, optical, and mechanicalsensors and detectable features (as the sensors and detectable features34 and 42) may be employed and are incorporated herein by reference toapply to embodiments having inductively detectable features andinductive sensors, as the sensors and detectable features 34 and 42.

Inductive sensors may be configured as non-contact proximity sensorsused to detect the presence of metallic or other electrically conductiveobjects. Thus, in particular embodiments, one or more inductivelydetectable members (or targets) includes one or more electricallyconductive materials attached to, embedded in or otherwise provided onthe cap 4. Such electrically conductive members (or targets) may be madeof any suitable electrically conductive material such as, but notlimited to, copper, gold, silver, nickel, a ferrous metal, otherconductive metals or other electrically conductive materials. Inparticular embodiments, the electrically conductive members (or targets)include electrically conductive ink or other electrically conductivematerial that is printed or otherwise applied to the cap 4. In furtherembodiments, the electrically conductive members (or targets) includeelectrically conductive polymer materials molded and/or formed asdesired. The inductively detectable members (or targets) may be passive(not powered by a separate power source).

In addition, one or more sensors are provided on the infusion pumpdevice 30, where each sensor includes (or is connected with) one or moreelectrically conducive coil. Each coil is attached to, embedded in orotherwise provided on the infusion pump device 30, in the region of thereservoir receptacle 32. Each electrically conductive coil may beconfigured with any suitable electrically conductive material such as,but not limited to, copper, gold, silver, nickel, a ferrous metal,conductive inks or other conductive metals or electrically conductivematerials, formed in a coil configuration suitable for inductiveinteraction with a target.

In particular embodiments, a single electrically conductive coil isprovided on the infusion pump device 30 and a single electricallyconductive member (or target) for inductive interaction with the coil isprovided on the cap 4 (or base/reservoir/cap unit). In otherembodiments, a plurality of electrically conductive coils are providedon the infusion pump device 30 (and/or a plurality of electricallyconductive members or targets are provided on the cap 4) in locationsthat allow the electrically conductive member(s) (target(s)) toinductively interact with the coil(s) to provide detectable signals fordetection of axial or rotational (angular) motion or position (or both)of the cap 4 relative to the reservoir receptacle 32. The detectablesignals provided by the interaction of the electrically conductivemember(s) (or target(s)) and the coil(s) are dependent, in part, onvarious parameters such as the distance between the electricallyconductive member and the coil, and the size, shape and material of theelectrically conductive member (or target). Accordingly, thoseparameters can be selected to provide a detectable signature that canindicate the presence of a cap 4 (or base/reservoir/cap unit) in a fullyinstalled position within reservoir receptacle, as well as otherinformation associated with the cap 4 (or the base/reservoir/cap unit)or the infusion set connected to the cap 4.

For example, in the embodiment of FIGS. 7 and 8, an electricallyconductive member or target 91 in the form of a metallic ring or band isprovided on the cap 4. FIG. 7 shows a perspective view of a portion ofan infusion pump device 30, with a base/reservoir/cap unit outside ofthe reservoir receptacle 32 of the infusion pump device 30. FIG. 8 showsan enlarged partial side, cross-section view of a portion of theinfusion pump device 30, with a base/reservoir/cap unit (only a portionshown in view) located within the reservoir receptacle 32.

In the embodiment in FIGS. 7 and 8, the target 91 is in the form of aring or band that is attached to an outer surface of the cap 4 andextends circumferentially around the axis A of the cap 4 (and reservoir1 of the base/reservoir/cap unit). In other embodiments, the ring orband of the target 91 is attached to an inner surface of the cap 4, oris embedded within a wall of the cap 4, for example, to minimize oravoid contact by the user or other objects (e.g., to minimize damage tothe target 91). In other embodiments, the target 91 has a shapedifferent from a ring or band (such as, but not limited to a triangularor arrow-head shape as shown in the embodiment of FIG. 9). In furtherembodiments, the target 91 is composed of a plurality of electricallyconductive members of the same shape or different shapes. For example, aplurality of electrically conductive members forming a target 91 may bearranged in a predetermined pattern to provide an induction signatureassociated with the target 91, where the induction signature isdependent at least in part on the number or pattern (or both) of theelectrically conductive members of the target 91.

Also in the embodiment in FIGS. 7 and 8, an electrically conductive coil93 of an inductive sensor (or separate but connected with an inductivesensor) is provided on the infusion pump device 30. The coil 93 is partof (or connected to) an inductive sensing circuit, such as, but notlimited to the circuit 95 in FIG. 9. In the embodiment in FIGS. 7 and 8,the coil 93 extends around the circumference of the reservoir receptacle32 of the infusion pump device 30, and around the axis A of thereservoir receptacle 32. In particular embodiments, the coil 93 includesa metallic wire or other electrically conductive material that is woundaround the axis A and attached to, embedded within or otherwise providedon a wall forming the reservoir receptacle 32 of the infusion pumpdevice 30. In other embodiments, the coil is attached to, embeddedwithin or otherwise provided on the wall forming the reservoirreceptacle 32 of the infusion pump device 30, but not circumferentiallyaround the axis A of the reservoir receptacle 32.

In further embodiments, the upper end (reservoir-receiving end) of thereservoir receptacle 32 includes an upper ring member 94 that isattached to the lower portion of the reservoir receptacle 32, where thecoil 93 is attached to, embedded within or otherwise provided on thering member 94. This allows the coil 93 and ring member 94 to be madeseparately from the rest of the infusion pump device 30 and thenassembled with the infusion pump device 30 during or after manufactureof the infusion pump device 30. In such embodiments, the ring member 94may be made of any suitably rigid material, such as but not limited toplastic, metal, ceramic, composite material or combinations thereof. Thering member 94 is attached to the rest of the reservoir receptacle 32 byany suitable attachment mechanism including, but not limited to,welding, glue, resin or other adhesive material, screw threads, frictionfit, or the like.

The ring member 94 is arranged at a location on the reservoir receptacle32 to allow the coil 93 to inductively interact with the target 91 onthe cap 4, when (or as) the cap is received within the reservoirreceptacle. For example, the coil 93 may be disposed on the ring member94 in a location where the coil 93 will be adjacent and in sufficientproximity to the target 91, when (or as) the cap is received within thereservoir receptacle 32 such that the target 91 is in sufficientproximity to the coil 93 to causes (by induction) a detectable change ina current flowing in the coil 93 (and in the circuit 95 in FIG. 9).

In one example embodiment, a sensor 34 is connected in an electronicdetection circuit with the coil 93 (for example, in the circuit 95 inFIG. 9). FIG. 9 shows a generalized diagram of an electronic detectioncircuit. In the circuit 95, a current source 96 is connected across thecoil 93, and the sensor 34 is connected between the current source 96and the coil 93. The circuit 95 includes a tank circuit formed with acapacitor 97 connected across the coil 93. With current from the currentsource 96, the coil 93 in the circuit 95 provides a time-varyingmagnetic field. Changes in the position and motion of the target 91within that magnetic field produces detectable changes in the inductanceof the coil 93 and the equivalent resistance of the circuit 95. Inparticular embodiments, the sensor 34 provides an output signal toprocessing electronics (such as processing electronics 62 in FIG. 5),where the sensor output signal is dependent upon the inductance of thecoil and resistance or impedance of the circuit (and, thus, dependentupon motion and position of the target 91 relative to the coil 93). Infurther embodiments, the sensor 34 may be composed of an electrical linkto processing electronics (such as processing electronics 62) thatprocesses the signal in the circuit 95 to determine the presence of thetarget 91 or other information from that signal.

The target 91 is attached to the cap 4 at a location and position suchthat the target 91 moves in the direction of arrow 98 relative to thecoil 93, when the cap 4 (or base/reservoir/cap unit) moves into thereservoir receptacle 32 of the infusion pump device 30. As a result, thetarget 91 moves to a position adjacent the coil 93 (or to a differentposition adjacent the coil 93 relative to a starting position), when thecap 4 (or base/reservoir/cap unit) moves into the reservoir receptacle32 of the infusion pump device 30. In the drawing of FIG. 9, the target91 is shown in solid line and again in broken line, to represent twodifferent positions of the target 91 and a movement from the solid lineposition to the broken line position, in the direction of arrow 96.

The movement and change of position of the target 91 adjacent andrelative to the coil 93 produces a detectable effect on the currentsignal in the circuit 95, at least partially depend upon (a function of)the distance between the target 91 and the coil 93, and the size, shapeand composition of the target 91. The position of the target 91 relativeto the coil 93 after the target 91 has been moved in the direction ofarrow 96 produces a detectably different signal in the circuit 95relative to the signal when the target 91 is not adjacent to the coil 93(e.g., prior to installation of the cap 4 or after removal of the cap 4from the reservoir receptacle 32).

In particular embodiments, the sensor 34 (or processing electronics 62)is configured to detect the inductance (or other parameter) associatedwith the tank circuit in circuit 95 without the target 91 present (e.g.,before installation of a cap 4 or base/reservoir/cap unit). Thisprovides the sensor 34 (or processing electronics 62) with a base orcalibration value associated with the target 91 not being present. Then,after the cap 4 (or base/reservoir/cap unit) is installed in thereservoir receptacle, the sensor 34 (and processing electronics 62) areconfigured to detect the changed inductance (or other parameter)associated with the tank circuit in circuit 95 when the target 91 ispresent (relative to the base or calibration value). When the change inthe inductance (or other parameter) is detected, the processingelectronics 62 determines (in response to that detection) that a cap 4(or base/reservoir/cap unit) has been installed.

In an embodiment described above, the target 91 is provided in the formof a ring or band around the cap 4. In other embodiments, the target 91can be formed as a partial ring or band, or may have another shape. Forexample, in the embodiment in FIG. 9, the target 91 has a triangularshape (or tapered, arrow-head shape) having first and second oppositeends, where the first end 91 a has a smaller width dimension (e.g., thehorizontal dimension in FIG. 9) than the second end 91 b. In thatembodiment, as the cap 4 is moved into the reservoir receptacle 32, thefirst end 91 a (smaller dimension end) of the target 91 moves toward thecenter (or across) the coil 93 followed by the second end 91 b (largerdimension end) of the target 91. As such, the first end 91 a (smallerdimension end) of the target 91 will effect eddy currents, followed byan effect on eddy currents by the second end 91 b (larger dimension end)of the target 91, resulting in a time varying signal that is at leastpartially dependent on the shape and direction of motion of the target91.

Similarly, when the cap 4 (or base/reservoir/cap unit) is moved in adirection out of the reservoir receptacle 32 (opposite to the directionof arrow 96), the second end 91 b (larger dimension end) of the target91 will be in front of the first end 91 a (smaller dimension end) of thetarget 91 in the direction of motion, causing a detectable effect oneddy currents different from the effect of moving in the direction ofarrow 96. Accordingly, the movement of the cap 4 (or base/reservoir/capunit) results in a time varying signal (or detectable signature) in thecircuit 95 that is partially dependent on the direction of motion of(into or out of the reservoir receptacle) and the size and shape of thetarget 91.

In particular embodiments, the infusion pump device 30 is operable withany of a plurality of different caps 4 (or base/reservoir/cap units),where each cap (or each base/reservoir/cap unit) has one or more targets91 that produce a different detectable signal in the circuit 95 (and,thus, has a detectably different signature) relative to each other cap 4of the plurality of different caps 4. For example, caps 4 (orbase/reservoir/cap units or associated infusion sets) from differentmanufacturers, for different reservoirs, for different reservoircontents, or having other differing features (relative to other caps 4or base/reservoir cap units or associated infusion sets) can have acorrespondingly different target 91 (e.g., a different shape, size,material or combination thereof), to produce a different detectablesignal (or target signature) relative to such other caps 4 orbase/reservoir cap units or associated infusion sets. In particularembodiments, processing electronics (such as processing electronics 62)are configured to determine information about a cap 4 (orbase/reservoir/cap unit), based on the detectable signal (or signature)produced when the cap 4 (or base/reservoir/cap unit) is moved in thedirection of arrow 96 (or opposite direction) as the cap 4 is installedor removed from the reservoir receptacle, or when the cap 4 is in aninstalled position.

For example, processing electronics (such as processing electronics 62in FIG. 5) may be configured to perform a process 150 as described abovewith respect to FIG. 6, but where the detectable parameters are signalparameters effected by features of the target 91, such as, but notlimited to the size, shape, material, or number of electricallyconductive members in the target 91, or the number of targets 91 andposition of the target(s) 91 on the cap (or base/reservoir/cap unit), orany combination thereof. In such embodiments, a memory associated withthe processing electronics (such as memory 66 associated with processingelectronics 62) stores data in association with possible detectablesignal parameters (or target signatures). The processing electronics 62are configured to compare parameters of a detected signal (or a detectedtarget signature) with stored parameters and obtain from the storeddata, certain selected data that is associated with parameters of thedetected signal (or target signature).

The stored data may include, but is not limited to, data correspondingto a plurality of different models, sizes, types or styles of caps 4 (orbase/reservoir/cap units, reservoirs or associated infusion sets),manufacturers of the caps 4 (or base/reservoir/cap units, reservoirs orassociated infusion sets), the type of infusion media in the reservoir 1(such as, but not limited to the type of insulin, other drug or othermedia), the concentration of the infusion media in the reservoir 1, thevolume amount of infusion media in the reservoir 1, a date (such as, butnot limited to a date corresponding to an expiration date, fill date orother date related to the infusion media in the reservoir 1 or thereservoir 1 itself), a location (such as, but not limited to a locationcorresponding to the place where the reservoir 1, the cap 4, or infusionmedia in the reservoir 1 (or all) was made, filled, or otherwiseprocessed, or a location for authorized use of the reservoir 1), a lotnumber (or other code associated with the batch in which the reservoir 1or infusion media was made, cleaned, filled or otherwise processed), aserial number, a unique ID, a manufacture date, user identificationinformation (for authorized users of the reservoir 1), or otherpredefined data or characteristic associated with the caps (orbase/reservoir/cap units, reservoirs or associated infusion sets). Inthis manner, the processing electronics can determine variouscharacteristics of or information about the cap 4 (or base/reservoir/capunit, reservoir 1 or associated infusion set) from the detected signal(or signature) produced as the cap 4 (or base/reservoir/cap unit) isinstalled or removed from the infusion pump device 30, or when the cap 4(or base/reservoir/cap unit) is in an installed position.

While the embodiment in FIG. 9 has a target 91 in the shape of atriangle, other embodiments employ targets 91 having other suitableshapes or combinations of shapes. For example, the target 91 in theembodiment in FIGS. 7 and 8 has a ring or band shape. In particularembodiments, the shape of the target 91 or the pattern of plural targets91 (or the shape and pattern) is selected to provide a detectablydifferent signal when the target 91 is moved in the direction of arrow96 (e.g., into the reservoir receptacle 32) relative to the signalproduced when the target 91 is moved in the direction opposite to thedirection of arrow 96 (e.g., out from the reservoir receptacle 32). Inthis manner, the processing electronics 62 may be configured to detectsuch different signals, to determine whether the cap 4 (orbase/reservoir/cap unit) is being installed or being removed from thereservoir receptacle.

The shape, size and material of the target 91 and the number and patternof plural targets 91 can affect the eddy currents and, thus, thedetectable signal (or signature) produced when the target 91 is moved orlocated adjacent the coil 93. Accordingly, one or more of the shape,size and material of the target 91 and the number and pattern of pluraltargets 91 can be selected to provide a particular unique or non-uniquedetectable signal (or signature), as described above.

In particular embodiments, the cap 4 (or base/reservoir/cap unit) mayinclude a plurality of targets 91, or the infusion pump device 30 mayinclude a plurality of coils 93 (or both), arranged in differentpositions along the axis A or around the axis A (or both). In suchembodiments, the position of the cap 4 (or base/reservoir/cap unit)relative to the length dimension of the axis A or relative to acircumference around the axis A (or both) can be detected, to detect thelinear position or the rotational position (or both), of the cap 4 (orbase/reservoir/cap unit) relative to the axis A (and, thus, relative tothe reservoir receptacle 32 of the infusion pump device 30). Forexample, rotational position can be detected with a plurality of targets91 and/or a plurality of coils 93, in a manner similar to the pluralityof sensors and plurality of detectable members 34 and 42 in FIGS. 4A and4B.

In certain embodiments described above, the target(s) 91 are provided onthe cap 4 (or base/reservoir/cap unit), while the coil(s) 93 areprovided on the infusion pump device 30. In other embodiments, thetarget(s) 91 and the coil(s) 93 are, both, provided on the infusion pumpdevice 30. In example embodiments, one or more targets 91 are supportedon the infusion pump device 30 with a corresponding one or more coils93, where each target 91 is held by a support structure that moves thetarget 91 in a predefined direction upon and in response to theinstallation of the cap 4 (or base/reservoir/cap unit) in the reservoirreceptacle 32 of the infusion pump device 30.

Representative examples of mechanically moveable support structures formoving a target 91 in response to the installation of a cap 4 (orbase/reservoir/cap unit) in a reservoir receptacle 32 are described withreference to FIGS. 10-15. The drawings in FIGS. 10 and 11 show enlargedpartial cross-section views of a portion of the infusion pump device 30.In FIG. 10, the reservoir receptacle 32 of the infusion pump device 30is free of the cap 4 (base/reservoir/cap unit.). In FIG. 11, the cap 4(base/reservoir/cap unit.) is installed in the reservoir receptacle 32of the infusion pump device 30.

In FIGS. 10 and 11, the infusion pump device 30 holds a mechanicallymoveable member or actuator. The mechanically moveable member (actuator)is arranged to engage an engagement portion of the cap 4 (or othercomponent of the base/reservoir/cap unit) and to be moved from the firstposition to the second position, as a result of a manual movement of thecap 4 (or base/reservoir/cap unit) into the reservoir receptacle 32 andto a proper and fully received position within the reservoir receptacle32.

The mechanically moveable member carries one or more targets 91 (oneshown in FIGS. 10 and 11), and moves the target(s) 91 relative to one ormore respective coils 93 (one shown in FIGS. 9 and 10), when themechanically moveable member is moved to the second position.Accordingly, a manual movement of the cap 4 (or base/reservoir/cap unit)into the reservoir receptacle 32 and to a proper and fully receivedposition within the reservoir receptacle 32 causes the mechanicallymoveable member to move in a predefined direction to the second positionand, thus, move one or more targets 91 adjacent and relative to one ormore coils 93. Each coil 93 is connected in a circuit (such as discussedabove with respect to circuit 95) for detecting whether or not an target91 has moved to the second position. Accordingly, by detecting the stateor position of the target 91, the electronics determines whether or notthe cap 4 (or base/reservoir/cap unit) is properly and fully receivedwithin the reservoir receptacle 32.

In the embodiment of FIGS. 10 and 11, a mechanically moveable member 70is supported for movement within a channel 72 located in the infusionpump device 30. The moveable member 70 in FIGS. 10 and 11 has agenerally elongated shaft or cylinder shape and is made of a suitablyrigid material that holds its shape during normal operation such as, butnot limited to plastic, metal, ceramic, wood, composite material, or anycombination thereof. In other embodiments, the moveable member 70 mayhave any other suitable shape or form.

The channel 72 may be formed within the structure of the housing 33 ofthe infusion pump device 30 or within a further structure located withinthe housing 33. A first end of the channel 72 is open into the reservoirreceptacle 32. A second end of the channel 2 is open into anotherportion of the interior of the housing 33 of the infusion pump device30. In the illustrated embodiment, the channel 72 is linear along alongitudinal dimension (horizontal dimension in FIGS. 10 and 11), andthe moveable member 70 has a corresponding longitudinal shape thatextends along the longitudinal dimension of the channel 72. In otherembodiments, the channel 72 (and the moveable member 70) may havecorrespondingly curved shapes or other suitable shapes that allow themoveable member 70 to move between first and second positions within thechannel 72.

The moveable member 70 has a first end 74 (the end on the right side ofthe moveable member 70 in FIGS. 10 and 11) that holds a target 91. Thetarget 91 may be attached to the moveable member 70 in any suitablemanner including, but not limited to adhesives, screws, bolts, clamps orother mechanical connectors, or by embedding or molding the target 91into the moveable member 70. The moveable member 70 has a second end 78(the end on the left side of the moveable member 70 in FIGS. 10 and 11)that is arranged to be engaged by an engagement portion 80 of the cap 4(or other component of the base/reservoir/cap unit) when the cap 4 (orbase/reservoir/cap unit) is properly and fully received within thereservoir receptacle 32.

More specifically, the engagement portion 80 of the cap 4 (or othercomponent of the base/reservoir/cap unit) has a contact surface thatcomes into contact with and engages a surface of the second end 78 ofthe moveable member 70, as the cap 4 (or the base/reservoir/cap unit) ismanually inserted and moved into a proper and fully inserted positionwithin the reservoir receptacle 32 of the infusion pump device 30. Asthe cap 4 (or the base/reservoir/cap unit) is manually moved toward theproper and fully inserted position within the reservoir receptacle 32,the engagement portion 80 engages the second end 78 of the moveablemember 70. Then, further movement of the cap 4 (or thebase/reservoir/cap unit) toward the a proper and fully inserted positioncauses the engagement portion 80 to push the second end 78 of themoveable member 70 and move the moveable member 70 in the direction ofarrow 69 from a first position (shown in FIG. 9) to a second position(shown in FIG. 10).

The movement of the moveable member 70 from the first position (FIG. 10)to the second position (FIG. 11) causes the first end 74 of the moveablemember 70 to move the target 91 adjacent and relative to the coil 93.The coil 93 is supported on the infusion pump device 30 (for example,within the housing 33) in a position adjacent and along the path ofmotion of the target 91, in sufficient proximity to the target 91 forinductive detection as described above. Accordingly, the target 91 ismoved relative to the coil 93 by movement of the moveable member 70 (anddetectable as described above), when the cap 4 (or thebase/reservoir/cap unit) is moved to the proper and fully insertedposition within the reservoir receptacle 32.

In particular embodiments, the engagement portion 80 on the cap 4 (orthe base/reservoir/cap unit) has a feature (a protrusion, bump,extension, depression or the like) having the contact surface thatengages the second end 78 of the moveable member 70, when the cap 4 (orthe base/reservoir/cap unit) is in a fully and properly insertedposition within the reservoir receptacle 32. In such embodiments, theprotrusion (or other feature) may be shaped and located at a particularposition on the cap 4 (or the base/reservoir/cap unit) to engage (orfully engage) the second end 78 of the moveable member 70 sufficient tomove the moveable member 70 to the second position, only when the cap 4(or the base/reservoir/cap unit) is fully and properly inserted withinthe reservoir receptacle 32. In such embodiments, the target 91, circuit95 (including coil 93) and processing electronics 62 are configured todetect movement of the moveable member 70 to the second position, or todetect the presence of the moveable member 70 at the second position (orboth), for example, to determine that the cap 4 (or thebase/reservoir/cap unit) is fully and properly installed. In furtherembodiments, the target 91, circuit 95 (including coil 93) andprocessing electronics 62 are configured to detect movement of themoveable member 70 to one or more positions other than the secondposition, or to detect the presence of the moveable member 70 at suchone or more other positions (or both), for example, to determine thatthe cap 4 (or the base/reservoir/cap unit) is not fully or properlyinstalled in the reservoir receptacle 32.

In further embodiments, the protrusion (or other feature) of theengagement portion 80 has a predetermined size that results in amovement of the moveable member 70 in the direction of arrow 69 by apredetermined amount (corresponding to the predetermined size), when thecap (or the base/reservoir/cap unit) is fully and properly installed inthe reservoir receptacle 32. Thus, engagement portion features ofdifferent sizes will result in different amounts of movement of themoveable member 70 (and of the target 91), when the cap (or thebase/reservoir/cap unit) is installed in the reservoir receptacle 32. Inparticular embodiments, the size of the engagement portion feature isselected to provide a particular unique or non-unique detectable signal(or target signature), where parameters of that target signature areemployed by processing electronics 62 (of FIG. 5) as detected parametersin a process 150 as described with respect to FIG. 6.

In such further embodiments, multiple different predetermined sizes ofthe engagement portion features (such as multiple different lengths ofthe protrusion) may be associated (on a one-to-one basis or otherpre-defined association) with predefined data (e.g., stored in memory66) corresponding different predefined characteristics of the cap 4 (orthe base/reservoir/cap unit or associated infusion set), as describedabove with respect to FIG. 6. The predefined data may include, but isnot limited to, data corresponding to a plurality of different models,sizes, types or styles of caps 4 (or base/reservoir/cap units,reservoirs or associated infusion sets), manufacturers of the caps 4 (orbase/reservoir/cap units, reservoirs or associated infusion sets), thetype of infusion media in the reservoir 1 (such as, but not limited tothe type of insulin, other drug or other media), the concentration ofthe infusion media in the reservoir 1, the volume amount of infusionmedia in the reservoir 1, a date (such as, but not limited to a datecorresponding to an expiration date, fill date or other date related tothe infusion media in the reservoir 1 or the reservoir 1 itself), alocation (such as, but not limited to a location corresponding to theplace where the reservoir 1, the cap 4, or infusion media in thereservoir 1 (or all) was made, filled, or otherwise processed, or alocation for authorized use of the reservoir 1), a lot number (or othercode associated with the batch in which the reservoir 1 or infusionmedia was made, cleaned, filled or otherwise processed), a serialnumber, a unique ID, a manufacture date, user identification information(for authorized users of the reservoir 1), or other predefined data orcharacteristic associated with the caps (or base/reservoir/cap units,reservoirs or associated infusion sets). The associations of featuresizes and data can be stored in a memory (such as memory 66), asdescribed with respect to 152 in process 150 of FIG. 5.

The stored associations are used by processing electronics (such asprocessing electronics 62) to determine one or more characteristics of acap (or base/reservoir/cap unit), reservoir 1 (or its contents),infusion set 50, connection interface 40, or any combination thereof, asdescribed with respect to 156 and 158 in process 150 of FIG. 5. Inaddition, such processing electronics may be configured to provide apredefined action based on or using the determined characteristic(s), asdescribed with respect to 160 in process 150 of FIG. 5. In this manner,the processing electronics 62 may be configured to detect information(e.g., the associated predefined characteristics) about the cap 4 (orthe base/reservoir/cap unit or associated infusion set), by detectingthe amount of movement of the moveable member 70 in the direction ofarrow 69 (or the position of the target 91) when the cap 4 (or thebase/reservoir/cap unit) is installed in the reservoir receptacle 32,and by retrieving information associated with the detected amount ofmovement.

In particular embodiments, the second end 78 of the moveable member 70extends a small distance into the reservoir receptacle 32, when themoveable member 70 is in the first position (FIG. 10). In that position,the second end 78 of the moveable member 70 is arranged in a location tobe contacted by the engagement portion 80 of the cap 4 (or thebase/reservoir/cap unit) as the cap 4 (or the base/reservoir/cap unit)is moved toward a proper and fully inserted position within thereservoir receptacle 32. In particular embodiments, the second end 78 ofthe moveable member 70 is rounded, tapered or provided with anothersuitable shape that helps to transfer the linear motion of the cap 4 orthe base/reservoir/cap unit (e.g., downward motion in the direction ofthe reservoir receptacle 32 in FIGS. 10 and 11) to linear motion of themoveable member 70 along the longitudinal dimension of the channel 72,as the cap 4 (or the base/reservoir/cap unit) is moved toward a properand fully inserted position within the reservoir receptacle 32.

In particular embodiments, the second end 78 of the moveable member 70extends into the channel of the reservoir receptacle 32 by a distancesufficient to contact an outer surface of the cap 4 (or thebase/reservoir/cap unit) and ride along that outer surface (allow thatouter surface to slide over the second end 78 of the moveable member 70)without moving to the second position and, thus, without moving thetarget 91 relative to the coil 93, as the cap 4 (or thebase/reservoir/cap unit) is manually inserted into the reservoirreceptacle 32 and rotated toward a proper position. When the cap 4 (orbase/reservoir/cap unit) is properly and fully received (inserted androtated into proper position) in the reservoir receptacle 32, theengagement portion 80 on the cap 4 (or the base/reservoir/cap unit)comes into engagement with the second end 78 of the moveable member 70and imparts a sufficient force onto the moveable member 70 to move thetarget 91 in the direction of arrow 69 to the second position.

In particular embodiments, the second end 78 of the moveable member 70(or the entire moveable member 70) is made of a material that issufficiently compliant, flexible and resilient to be compressed at leastat the second end 78 by the engagement portion 80, when the second end78 of the moveable member 70 is contacted by the engagement portion 80.For example, the material may be sufficiently compliant and flexible toaccommodate for different cap 4 sizes or for manufacturing tolerances(or both). Thus, the second end 78 of the moveable member 70 may extendinto the reservoir receptacle 32 by a distance sufficient to contact acap 4 having any size outer diameter (within a predefined range), bycompressing sufficiently to accommodate larger diameters within thatrange.

In particular embodiments in which the moveable member 70 shifts towardthe switch when moving from the first position to the second position,the moveable member 70 includes or is engaged by a bias member 82 thatimparts a bias force on the moveable member 70 to bias the moveablemember 70 toward the first position (FIG. 9 position). The bias member82 may be any suitable structure or device that imparts a force on themoveable member 70 in the direction of the first position, such as, butnot limited to a coil spring, a leaf spring, other spring configuration,a magnet, a balloon or other pressurized expandable container, or thelike. In the drawings of FIGS. 10 and 11, a coil spring is shown as oneexample of a bias member 82.

In such embodiments, the moveable member 70 includes a protrusion,extension or other structure that provides a stop surface for stoppingfurther motion of the moveable member 70 in the direction of the firstposition, when the moveable member 70 reaches the first position. In theembodiment of FIGS. 10 and 11, the moveable member 70 includes aprotruding shoulder 84 that provides the stop surface. In theillustrated embodiment, the protruding shoulder 84 is arranged outsideof the channel 72 and adjacent the second end of the channel 72. Theprotruding shoulder 84 is configured to be larger (wider) than adimension (e.g., the width dimension) of the channel 72, so that theprotruding shoulder is not able to pass through the channel.Accordingly, the protruding shoulder 84 provides a stop surface (e.g., asurface of the shoulder 84) that engages a surface of the structure inwhich the channel 72 is located, when the moveable member 70 is in thefirst position (FIG. 10). However, the protruding shoulder 84 is spacedapart from that surface of the structure in which the channel 72 islocated, when the moveable member 70 is in the second position (FIG.11), or is between the first and second positions.

In particular embodiments, one or more seals or other features areprovided for inhibiting the passage of moisture, liquid or other fluidthrough the channel 72, for example, in the event that moisture, liquidor other fluid enters the reservoir receptacle 32. Thus, the passage ofmoisture, liquid or other fluid from the reservoir receptacle 32 toother areas within the infusion pump housing 33 can be inhibited, forexample, in the event that the infusion pump device 30 is exposed tomoisture, liquid or other fluid (such as, for example, rain, pool water,shower water, or the like).

In the embodiment of FIGS. 10 and 11, the moveable member 70 is providedwith one or more (two shown in the drawings) seal structures 86, forsealing against the interior surface of the channel 72. In theillustrated embodiment, two seal structures 86 are provided on themoveable member 70. In other embodiments, a single one or more than twoseal structures 86 may be employed. In particular embodiments, each sealstructure 86 includes a protruding extension or ring of material aroundthe movable member 70 (e.g., around the circumference of the shaft orcylindrical structure of the moveable member 70). In certainembodiments, one or more seal structures 86 are formed of the samematerial as the moveable member 70 and is either formed as part of themoveable member 70 (e.g., molded or machined, or the like, with themoveable member 70) or formed separately and attached to the moveablemember 70. In certain embodiments, one or more seal structures 86 arecomposed of an O-ring made of the same material as the moveable member.In other embodiments, one or more seal structures 86 are composed of anO-ring made of a different material as the moveable member, such as aflexible, resilient material suitable for sealing functions, including,but not limited to a rubber, plastic or silicone material.

The drawings in FIGS. 12-14 show further embodiments in which a target91 is held by a support structure that allows the target 91 to move in apredefined direction upon and in response to the installation of the cap4 (or base/reservoir/cap unit) in the reservoir receptacle 32 of theinfusion pump device 30. Each of FIGS. 12 and 13 show enlarged,cross-section views of a portion of an infusion pump device 30 and aportion of a cap 4. In FIG. 12, the reservoir receptacle 32 of theinfusion pump device 30 is free of the cap 4 (and base/reservoir/capunit.). In FIG. 13, the cap 4 (and base/reservoir/cap unit.) isinstalled in the reservoir receptacle 32 of the infusion pump device 30.FIG. 14 shows an enlarged, cross-section view of a portion of aninfusion pump device 30 and a portion of a cap 4 according to anotherembodiment.

In FIGS. 12 and 13, the coil 93 is contained in and held by the infusionpump device 30. In particular embodiments, the coil 93 is attached to orembedded in a housing wall of the infusion pump device (such as a walldefining a portion of the reservoir receptacle). The target 91 in FIGS.12 and 13 is also contained in and held by the infusion pump device 30.In particular, the target 91 is attached to the housing 33 of theinfusion pump device 30, through a mechanical linkage 97 that supportsthe target 91 for linear movement along the direction of the axis A ofthe reservoir receptacle 32.

The mechanical linkage 97 supports the target 91 for movement from afirst position (as shown in FIG. 12) before the cap 4 (orbase/reservoir/cap unit) is fully received within the reservoirreceptacle 32, to a second position (as shown in FIG. 13) after the cap4 (or base/reservoir/cap unit) is fully received or installed within thereservoir receptacle 32. In particular embodiments, the mechanicallinkage 97 biases the target 91 toward the first position (shown in FIG.12), to cause the target 91 to remain in or move to the first positionwhen the cap 4 (or base/reservoir/cap unit) is not fully received withinthe reservoir receptacle 32 (and out of engagement with the target 91).

However, as the cap 4 (or base/reservoir/cap unit) is received in thereservoir receptacle 32 and moved toward a fully installed position, anengagement portion 80′ on the cap 4 (or base/reservoir/cap unit) engagesand contacts the target 91 and moves the target 91 toward the secondposition. When the cap 4 (or base/reservoir/cap unit) is fullyinstalled, the engagement portion 80′ remains engaged with the target 91and holds the target 91 in the second position (as shown in FIG. 13).When the cap 4 (or base/reservoir/cap unit) is removed from thereservoir receptacle, the target 91 is released and allowed to move backto the first position (as shown in FIG. 12), for example, under the biasforce of the mechanical linkage 97.

In particular embodiments, the engagement portion 80′ is a surface of arib or bottom edge of a portion of the cap 4 and extends fully aroundthe circumference of the cap 4 (around the axis A, when the cap 4 isarranged within the reservoir receptacle 32). In other embodiments, theengagement portion 80′ includes one or more bumps, ramps or otherprojecting portions of the cap 4, arranged at one or more selectedlocations, spaced around the circumference of the cap 4, to align withthe target 91 when (or only when) the cap 4 is received within thereservoir receptacle 32 in a proper rotational position (rotationalposition about the circumference of the axis A) relative to thereservoir receptacle 32. Alternatively or in addition, the engagementportion 80′ may be arranged at any one of a plurality of locations alongthe linear dimension of the axis A to move the target 91 by an amount(along the linear dimension of axis A) dependent upon the location (inthe linear dimension) of the engagement portion 80′. Thus, a cap 4 withan engagement portion 80′ as shown in FIGS. 12 and 13 will engage atarget 91 and move the target 91 a greater distance that a cap 4 with anengagement portion 80″ as shown in FIG. 14 (where the engagement portion80″ is located a greater distance away from the bottom edge of the cap 4relative to the distance of the engagement portion 80′ from the bottomedge of the cap 4).

The coil 93 is supported within the infusion pump device 30, at alocation to interact in a detectable manner with the target 91 asdescribed above, when the target 91 moves to or is located at the secondposition (FIG. 13 or FIG. 14). More specifically, the movement orposition of the target 91 produces a detectable signal in coil 93 (andcircuit 95). However, because the target 91 is moved to a secondposition in FIG. 13 that is different from the second position in FIG.14, the detectable signal (or target signature) produced in the coil 93(and circuit 95) is different for the target position in FIG. 13relative to that of FIG. 14. In particular embodiments, processingelectronics (such as processing electronics 62) is configured to discernbetween a detectable signal (or target signature) provided when thetarget 91 is moved to a second position of FIG. 13 relative to adifferent detectable signal (or different target signature provided whenthe target is moved to a second position of FIG. 14. While theembodiments in FIGS. 13 and 14 show two different caps 4 withrespectively different engagement portion locations in the lineardimension of axis A, in other embodiments, more than two different caps4 are provided with respectively different engagement portion locations(different locations along the linear dimension of the axis A, thecircumference of the axis A or a combination thereof) to engagedifferent targets 91 or to move an engaged target 91 by differentamounts relative to each other cap 4. In this manner, different caps (ordifferent types of caps or base/reservoir/cap units) may be configuredto provide different target signatures, by virtue of having differentengagement portion locations.

In the embodiments in FIGS. 12-14, a single coil 93 is arranged todetect the movement or location of the target 91, where a movement ofthe target by the distance shown in FIG. 13 provides a detectablydifferent signal (target signature) than the movement of the target bythe distance shown in FIG. 14. In other embodiments, multiple coils 93are arranged such that at least one coil is in a position to detect themovement or position of the target 91 when the target is moved to asecond position shown in FIG. 13, and at least one other coil is in aposition to detect the movement or position of the target 91 when thetarget 91 is moved to a second position shown in FIG. 14. Thus, inparticular embodiments, multiple coils 93 are arranged to correspond tomultiple different second positions of the target 91 for different caps4.

In certain embodiments, the coil 93 is attached to a surface of a walldefining a portion of the reservoir receptacle 32, for example, on aninside surface facing the interior of the reservoir receptacle, on anopposite facing surface of the wall or embedded within the wall. Inembodiments in which the coil 93 is on the opposite-facing surface orembedded within a wall of the reservoir receptacle 32, the wall is madeof a plastic or other suitable material that allows inductive couplingof the target 91 and the coil 93, through the wall, at least when thetarget 91 is at the second position (FIG. 12).

The linkage structure 97 may be any suitable structure that supports thetarget 91 for linear movement along the direction of the axis A. Suchlinkage structures may include, but are not limited to, rails, guidesurfaces, bias springs, or combinations thereof. One example of alinkage structure 97 is shown in FIG. 15 and includes a rail 97 a thathas a linear dimension, a platform 97 b that is supported by the rail 97a for movement in the linear dimension of the rail 97 a and thatprovides a surface for holding the target 91, and a spring 97 c that issupported by the rail 97 a and biases the platform toward one end of thelinear dimension of the rail 97 a. The rail 97 a is configured to coupleto (or is formed in) the inside surface of a wall of the reservoirreceptacle 32. In other embodiments, other suitable linkage structures97 are employed to support the target 91.

In the embodiments of FIGS. 10-14, a single mechanically movable member70 (FIGS. 10 and 11) or a single linkage-supported, moveable target 91(FIGS. 12-14) are shown. In other embodiments, two or more (a pluralityof) mechanically movable members (for example, similar to mechanicallymovable member 70 in FIGS. 10 and 11) or two or more (a plurality of)linkage-supported, moveable targets 91 (for example, similar to FIGS.12-14) are arranged within the reservoir receptacle 32, around or alongthe length direction of the axis A. In such embodiments, the pluralityof mechanically movable members or the plurality of linkage-supported,moveable targets are arranged to allow detection of the linear positionor rotational position (or both) of the cap 4 (or base/reservoir/capunit) relative to the axis A of the reservoir receptacle 32. Forexample, such rotational position detection can be carried out byprocessing sensor signals from sensors 34 in a manner similar to thatdescribed above with respect to the multiple sensor embodiments of FIGS.4A and 4B.

In embodiments in which two or more (a plurality of) mechanicallymovable members or linkage-supported, moveable targets are arranged atpredefined locations around or along the axis A of the reservoirreceptacle 32, a corresponding two or more coils 93 are arranged todetect the position of the cap 4 relative to the infusion pump device 30(e.g., for detecting a proper connection of the cap 4 or thebase/reservoir/cap unit with the infusion pump device 30).

In other embodiments, in addition to or as an alternative to detectingproper connection with the infusion pump device 30, one or moremechanically movable members or linkage-supported, moveable targets areemployed to detect one or more other characteristics associated with thecap 4 or the base/reservoir/cap unit or associated infusion set (orcomponents thereof) as discussed above with respect to the process 150in FIG. 6. Alternatively or in addition, the target signature(s)discussed above that depend on the position (in the linear dimension ofthe axis A) of the engagement portion 80′ may be employed to detect oneor more of such characteristics.

In such further embodiments, multiple different engagement portionlocations (along the length dimension of the axis A or around thecircumference of the axis A, or both) may be parameters associated (on aone-to-one basis or other pre-defined association) with correspondingdifferent predefined characteristics of the cap 4 (or thebase/reservoir/cap unit or associated infusion set), for use in aprocess 150 as described above with respect to FIG. 6. The predefineddata may include, but is not limited to, data corresponding to aplurality of different models, sizes, types or styles of caps 4 (orbase/reservoir/cap units, reservoirs or associated infusion sets),manufacturers of the caps 4 (or base/reservoir/cap units, reservoirs orassociated infusion sets), the type of infusion media in the reservoir 1(such as, but not limited to the type of insulin, other drug or othermedia), the concentration of the infusion media in the reservoir 1, thevolume amount of infusion media in the reservoir 1, a date (such as, butnot limited to a date corresponding to an expiration date, fill date orother date related to the infusion media in the reservoir 1 or thereservoir 1 itself), a location (such as, but not limited to a locationcorresponding to the place where the reservoir 1, the cap 4, or infusionmedia in the reservoir 1 (or all) was made, filled, or otherwiseprocessed, or a location for authorized use of the reservoir 1), a lotnumber (or other code associated with the batch in which the reservoir 1or infusion media was made, cleaned, filled or otherwise processed), aserial number, a unique ID, a manufacture date, user identificationinformation (for authorized users of the reservoir 1), or otherpredefined data or characteristic associated with the caps (orbase/reservoir/cap units, reservoirs or associated infusion sets). Theassociations of engagement portion locations and characteristics can bestored in a memory (such as memory 66), as described with respect to 152in process 150 of FIG. 5.

The stored associations are used by processing electronics (such asprocessing electronics 62) to compare and determine one or morecharacteristics of a cap (or base/reservoir/cap unit), reservoir 1 (orits contents), infusion set 50, connection interface 40, or anycombination thereof, as described with respect to 156 and 158 in process150 of FIG. 6. In addition, such processing electronics may beconfigured to provide a predefined action based on or using thedetermined characteristic(s), as described with respect to 160 inprocess 150 of FIG. 6. In this manner, the processing electronics 62 maybe configured to detect information (e.g., the associated predefinedcharacteristics) about the cap 4 (or the base/reservoir/cap unit orassociated infusion set), by detecting which ones of a plurality oftargets 91 are moved and/or the amount of movement of one or moretargets 91, when the cap 4 (or the base/reservoir/cap unit) is installedin the reservoir receptacle 32, and by retrieving information associatedwith the detected target movements or second (moved) positions.

Therefore, a particular characteristic may be associated with themovement of one or more mechanically movable members orlinkage-supported, moveable conductive members, or the location orpattern of locations of the particular mechanically movable members orlinkage-supported, moveable conductive members that are moved to thesecond position by the cap 4. In particular embodiments, each differentpredefined characteristic of the reservoir 1, infusion set 50 orconnection interface 40, is associated (for example, on a one-to-onebasis or other predefined association) with a respectively different oneor more predefined mechanically movable member or linkage-supported,moveable conductive member. In those embodiments, the processingelectronics 62 is configured to determine a characteristic of thereservoir 1, infusion set 50 or connection interface 40 from thedetectable signals caused by movement of one or more mechanicallymovable members or linkage-supported, moveable conductive members.

For example, the processing electronics 62 may be configured to compareinformation received from one or more sensors 34 (in circuits 95associated with coils 93) with information stored in a table or inanother suitable data arrangement. The table or other data arrangementis stored in the electronic memory 66. The table or other dataarrangement associates signals produced by movement of differentpredefined mechanically movable members or linkage-supported, moveableconductive members with a corresponding plurality of predefinedcharacteristics, as described herein with respect to the magnetic, RF,optical and mechanical detection embodiments and incorporated herein byreference.

In particular embodiments, based on one or more of the detectablesignals produced by movement of the one or more mechanically movablemembers or linkage-supported, moveable conductive members, theprocessing electronics 62 is further configured to determinecorresponding characteristics and, based on those characteristics, doone or more predefined actions such as, but not limited to: determineoperational settings for the infusion pump device 30, provide signals tothe drive device or other components of the infusion pump device 30,provide one or more alarm signals, and record data representing detectedstates or conditions of one or more of the cap 4, base/reservoir/capunit, and infusion pump device 30, as described above with regard tomagnetic detection, RF detection, optical and mechanical embodiments.

In further embodiments, one or more wireless or wired communicationdevices is provided on the infusion pump device 30 (or other deliverydevice) and is configured and controlled to transmit volume informationrelating to the volume of infusion fluid remaining in or dispensed fromthe reservoir 1 (or other information corresponding to detectedparameters of the one or more targets 91 or associated characteristics)for display on another electronic device separate from or located remotefrom the infusion pump device 30. In particular embodiments, thewireless communication device(s) are configured to connect forcommunication on a communication network (such as, but not limited tothe Internet), with one or more pre-defined network connected devices.Such one or more pre-defined network connected devices may be located atremote geographic locations relative to the infusion pump device 30 (orother delivery device). In particular embodiments, such networkconnected devices include a server configured to receive informationfrom the infusion pump device 30 (or other delivery device) or fromanother network connected device (such as a cradle, user computer, orthe like) that communicates with the infusion pump device 30 (or otherdelivery device). Such information may include, but is not limited toinformation corresponding to one or more detected parameters or one ormore associated characteristics, or other information regarding thereservoir 1, cap 4, base/reservoir/cap unit or infusion set as describedabove.

In such embodiments, the network connected server may be associated withan entity that records information, supplies associated products such asrefills or replacement parts, provides medical treatment or medicalinsurance to the user or the like. In one example, the network connectedserver is associated with the Carelink™ system of Medtronic Inc. Inother embodiments, the network connected server is one or more otherservers and associated entities. Accordingly, such information may beemployed by the server (or associated entity) to determine whether ornot (or when) to send refills, new or replacement reservoirs, caps,infusion set needle housings, infusion set tubing, or other componentsof the cap 4, base/reservoir/cap unit, or infusion set. In furtherembodiments, such information may be provided to the user's doctor orother medical treatment entity associated with the user (for tracking,diagnosing, adjusting treatment plans or other suitable uses). Thus, insuch embodiments, refills or replacement components may be sent tousers, automatically (without requiring the user to place an order), andusage information can be provided to the user's healthcare provider,insurance provider or other suitable entities, automatically.

In further embodiments, the network connected server is configured toprovide (and the infusion pump device 30 or other delivery device isconfigured to receive) information through the above-noted networkcommunication connection or other network connection. Such informationmay include, but is not limited to, instructions or recommendations forreplacing or refilling a reservoir 1, cap 4, base/reservoir/cap unit orinfusion set, messages or notices from healthcare providers, insurancecarriers or manufacturers, recall notices or the like. In particularembodiments, electronics (such as electronics 60) in the infusion pumpdevice 30 (or other delivery device) is configured to perform one ormore predefined actions (as discussed above) in response to receipt of apredefined instruction, notice or message.

In embodiments described above, the target(s) 91 is(are) provided on thecap 4 (or base/reservoir/cap unit) or in the infusion pump device 30. Inother embodiments as described with reference to FIG. 16, at least onetarget 91 is provided on a moveable plunger of the reservoir 1. FIG. 16shows an enlarged, partial, side cross-section view of a portion of theinfusion pump device 30, with a base/reservoir/cap unit (only a portionof which is shown in the drawing) received within the reservoirreceptacle 32. In FIG. 16, the at least one target 91 is provided on theplunger within the reservoir 1 (e.g., on the head 1 a of the reservoirplunger or the shaft 1 b of the reservoir plunger). In such embodiments,one or more coils 93 may be arranged in the infusion pump device 30(e.g., within or in the vicinity of the reservoir receptacle 32), todetect linear positions of the target 91 relative to the axis A, whenthe base/reservoir/cap unit is installed in the reservoir receptacle 32.Accordingly, based on the detected position of the target 91, processingelectronics (such as processing electronics 62) connected to anelectronic detection circuit associated with each coil 93 may beconfigured to detect the linear position of the plunger head 1 a and,thus, the amount of infusion media remaining in the reservoir 1.

In particular embodiments, the processing electronics is configured todetect the linear position of the plunger head 1 a and determine whetheror not the plunger head 1 a is in a filled position (corresponding to afilled or un-used reservoir 1), or whether or not the plunger head 1 ais in the last position from the previous use of the infusion pumpdevice 30. In such embodiments, the processing electronics may beconfigured to perform a predefined action in response to a determinationthat the plunger head is not in a filled position or is not in its lastposition (which may indicate that a used or re-used reservoir has beeninstalled in the infusion pump device). Such predefined action mayinclude, but is not limited to, inhibiting infusion media deliveryoperation of the infusion pump device 30, determining particularoperational settings for the infusion pump device 30, providing an alarmor control signals, recording data, providing authentication operations,or performing other predefined tasks.

Similar to embodiments discussed above, the target 91 on the plungerhead 1 a may have a predefined shape, size, material, or combinationthereof, to provide a detectable signal (or signature) that is based atleast in part on the shape, size, material or combination thereof. Alsosimilar to embodiments discussed above, a plurality of differentreservoirs 1 may include a corresponding plurality of different targets91 (with different respective shapes, sizes, materials, or combinationsthereof), to provide a corresponding plurality of different detectablesignals (signatures).

In such embodiments, processing electronics and associated memory (suchas processing electronics 62 and memory 66) are configured to compareparameters of detected signals (signatures) with pre-stored signalparameter information, and associate predefined data with the detectedsignals (signatures) as described above. The predefined data mayinclude, but is not limited to, data corresponding to a plurality ofdifferent models, sizes, types or styles of caps 4 (orbase/reservoir/cap units, reservoirs or associated infusion sets),manufacturers of the caps 4 (or base/reservoir/cap units, reservoirs orassociated infusion sets), the type of infusion media in the reservoir 1(such as, but not limited to the type of insulin, other drug or othermedia), the concentration of the infusion media in the reservoir 1, thevolume amount of infusion media in the reservoir 1, a date (such as, butnot limited to a date corresponding to an expiration date, fill date orother date related to the infusion media in the reservoir 1 or thereservoir 1 itself), a location (such as, but not limited to a locationcorresponding to the place where the reservoir 1, the cap 4, or infusionmedia in the reservoir 1 (or all) was made, filled, or otherwiseprocessed, or a location for authorized use of the reservoir 1), a lotnumber (or other code associated with the batch in which the reservoir 1or infusion media was made, cleaned, filled or otherwise processed), aserial number, a unique ID, a manufacture date, user identificationinformation (for authorized users of the reservoir 1), or otherpredefined data or characteristic associated with the caps (orbase/reservoir/cap units, reservoirs or associated infusion sets). Inthis manner, the processing electronics can determine variousinformation about the reservoir 1 or cap 4 (or base/reservoir/cap unitor associated infusion set) from the detected signal (or signature).

While the above description of FIG. 16 refers to inductive sensing, inother embodiments, the reservoir plunger 1 a may hold or contain amagnet, RF detectable member, or other detectable feature 42 asdescribed herein (instead of or in addition to a target 91). In suchembodiments, a corresponding sensor 34 (magnetic sensor or other sensoras described herein) is carried by the infusion pump device 30 at alocation to detect the detectable feature 42 as described herein.Accordingly, FIG. 16 is also referred to herein with respect to otherembodiments, in which one or more detectable features 42 are provided onthe reservoir plunger 1 a, and one or more sensors 34 are located in theinfusion pump device 30, for detection of the detectable feature(s).

In any of the inductive sensing embodiments described herein one or more(or each) coil 93 may be provided with a backing or shield forinhibiting electromagnetic interference from other components of theinfusion pump device 30 or external sources. For example, in particularembodiments, a shunt backing of ferrite (or other suitable) material isarranged adjacent one side of the coil, to inhibit passage ofelectromagnetic fields to or from that side of the coil. In furtherembodiments, the material and shape of the backing or shield isconfigured to direct a magnetic field of the coil 93 toward the target91. The backing or shield can be made in any suitable form including,but not limited to a plate-like member provided on one side (a backside) of the coil 93, a cage or enclosure containing the coil 93 andhaving an opening or other magnetic field guide directing the magneticfield toward the target 91. In embodiments in which the coil 93 isarranged on or in a wall of the infusion pump device 30, the backing orshield may be arranged on the same wall or on an opposite side of thewall, adjacent the location of the coil 93.

In inductive detection embodiments described with reference to FIGS.10-15, a bias member, such as a coil spring (82 in FIGS. 10 and 11, andbias member 97 c in FIG. 15) is provided to impart a bias force. Inthose embodiments, instead of or in addition to a coil 93 and target 91,the compression of the bias spring is detected by inductive sensing. Insuch embodiments, changes in the state (or amount) of compression of thebias spring provide detectable changes in an electrical signal in thebias spring, where a circuit (similar to circuit 95, but with the biasspring provided as the coil 91) is connected to the bias spring todetect such changes and perform operations as described above.

Inductive detection configurations described herein can provide variousadvantages. For example, like magnet detection embodiments describedherein, inductive detection can provide a reliable, contactless systemthat is relatively insensitive to certain environmental conductions,such as dust, dirt, moisture, or the like. Furthermore, particularinductive detection systems do not require magnets. Furthermore, ininductive detection systems the coil 93 may be arranged in proximity toan expected location of the target, but can be separated from the restof the circuit 95. Accordingly, the circuit 95 and electronics 60 may bearranged near the coil 93 or at other locations on the infusion pumpdevice 30, remote from the coil 93.

In particular embodiments as described above, one (or all) of the cap 4,reservoir 1, and the infusion pump device 30 is provided with at leastone sensor element, and the other (or both) of the cap 4 and theinfusion pump device 30 is provided with at least one detectable featurethat is detected by the sensor element(s) when the cap 4 is properlycoupled with the infusion pump device 30. Certain embodiments asdescribed above include one or more magnetic detectable features andmagnet detection sensors. In other embodiments described above, each ofthe one or more detectable features 42 includes an inductive device orstructure that can be detected by an inductive sensor, and each sensorelement 34 includes an inductive sensor. In yet other embodiments, theone or more detectable features 42 include a combination of magneticdetectable devices and inductive devices, while the one or more sensorelements 34 include a combination of one or more magnetic detectionsensors and one or more inductive sensors.

c. RF Detection

In particular embodiments as described above, one (or all) of the cap 4,reservoir 1, and the infusion pump device 30 is provided with at leastone sensor, and the other (or all) of the cap 4, reservoir 1, and theinfusion pump device 30 is provided with at least one detectable featurethat is detected by the sensor when the cap 4 is properly coupled withthe infusion pump device 30. Embodiments as described above include oneor more magnetic detectable features and magnet detection sensors, orone or more inductively detectable features and inductive sensors (orboth).

Other embodiments described herein (e.g., in sections, below) includeone or more detectable features that are detected by optical, mechanicalor electrical contact sensing configurations. In yet other embodiments,the one or more detectable features 42 includes a radio frequency (RF)detectable device or structure that can be detected by an RF sensor, andthe one or more sensor elements 34 includes an RF sensor. Thus, in oneexample, element 42 represents one or more RFID tags carried by the cap4, while element 34 represents one or more RF sensor elements in oradjacent the reservoir receptacle 32 of the infusion pump device 30.

Accordingly, arrangements and configurations of magnetic sensors andmagnetic detectable features (as the sensors and detectable features 34and 42) described above and shown in FIGS. 1-6 are incorporated hereinby reference to apply to embodiments employing RF detectable featuresand RF sensors, as the sensors and detectable features 34 and 42. Inaddition and where applicable, further arrangements and configurationsof inductive, optical, mechanical or electrical contact sensors anddetectable features (as the sensors and detectable features 34 and 42)described with respect to other embodiments herein are incorporatedherein by reference to apply to embodiments employing RF detectablefeatures and inductive sensors, as the sensors and detectable features34 and 42.

In particular embodiments, an RF detectable feature 42 includes a radiofrequency identification data (RFID) tag or any other suitable devicethat provides an RF signal that is detectable by an RF sensor. The RFdetectable feature may be a passive device that does not employ abattery power source. Examples of passive RF detectable devices includeinductive devices that are powered and read by RF sensor readers,through electromagnetic induction. In other embodiments, the RFdetectable feature is an active device that includes or is connected toa local power source, such as, but not limited to a battery, solar cell,or other local source of energy. In particular embodiments, the RFdetectable device includes data storage electronics that storesinformation readable by a suitable RF sensor. Various types of RFID tagsare made by a variety of companies including, but not limited to Impinjand NXP Semiconductors.

In particular embodiments, the RF detectable feature is configured as anRFID tag device that has an antenna coil and an electronic circuitelectrically connected to the coil. The electronic circuit may beprovided on a circuit board, in an electronic circuit chip (such as, butnot limited to a microchip) or in or on another suitable supportstructure. In certain embodiments, the electronic circuit is a passivecircuit that has no power source battery but, instead, receives powerthrough the antenna coil, from inductive coupling with a sensor. Inother embodiments, the electronic circuit in the RF detectable featureincludes or is connected with a battery power source (or other suitableactive power source). In an example embodiment, the RF detectablefeature is configured as a stick-on label having an adhesive-backedsubstrate sheet or base, with an RFID tag supported on the substratesheet or base (or adhered to, embedded in or inlayed into the substratesheet or base). In such embodiments, the RF detectable feature can beprovided in the form of a smart label that can be adhered directly to acap 4, reservoir 1, or other component of a base/reservoir/cap unit, orto the infusion pump device housing, or any combination thereof.

The RF detectable feature is configured to communicate RF signals at oneor more predefined frequencies or within one or more predefinedfrequency bands. In particular embodiments, the predefined frequenciesor bands are within a UHF band, for example, but not limited to 860-960MHz. Other embodiments may employ other suitable frequencies or bands.In embodiments in which a plurality of RF detectable devices areemployed in the system, each RF detectable devices may be configured tooperate in a different predefined frequency or band with respect to eachother of the RF detectable device in the system.

Also in particular embodiments, the electronic circuit included in theRF detectable feature is configured to store information and communicatestored information in an RF signal. The RF signal may be communicatedthrough inductive coupling with a sensor (for example, in a passivedevice embodiment) or by transmission with an active transmitter circuitincluded in the RF detectable feature (for example, in active deviceembodiments). Information stored by the RF detectable feature mayinclude, but is not limited to, one or more of: serial number or otheridentification information, a lot number, a unique ID number/code, EPCor other code, indicia or encoded information representing one or morepredefined characteristics of the reservoir, reservoir contents, cap 4or other component of the base/reservoir/cap unit, the infusion pumpdevice, any of the characteristics of the reservoir 1, infusion set 50,and connection interface 40 discussed in the above Magnetic detectionsection of the present specification, or the like.

In a passive device embodiment example, the RF detectable feature is anRF detectable device configured to receive an RF signal from a sensordevice (when the RF detectable device and the sensor device are insufficient proximity or alignment, or both), and is powered up by thereceived signal to communicate stored information back to the sensordevice, for example, via a back scatter signal. In an active deviceembodiment example, the RF detectable device is configured to activelytransmit stored information to a sensor device (when the RF detectabledevice and the sensor device are in sufficient proximity or alignment,or both). For example, the active RF detectable device may be configuredto transmit stored information at predefined intervals (or periodic orrandom intervals) of time. In other embodiments, an active RF detectabledevice may be configured to receive a request signal from a sensordevice when the RF detectable device and the sensor device are insufficient proximity or alignment (or both), where RF detectable deviceresponds to the request signal by transmitting the stored information.

The RF sensor device(s) may include, but are not limited to, an RFreader that includes electronics having an RF transceiver and modemcontrolled by a microprocessor (or other suitable processor) andelectrically connected with an antenna. In embodiments that employpassive RF detectable devices, the RF sensor device includes aninductive loop antenna and electronic circuitry configured to generatean AC magnetic field that induces a voltage across an antenna of apassive RF detectable device, when the RF detectable device and thesensor device are in sufficient proximity or alignment, or both. In suchembodiments, the RF sensor electronics are configured to receiveinformation from the RF detectable device, via a back scattered signal(as described above). In other embodiments, the RF sensor device(s)include other suitable devices that provide a detectable response to thepresence or alignment (or both) of an RF detectable device.

In particular embodiments, the RF sensor(s) are configured (or areconnected with electronics configured) to detect at least one of: (a)the presence of an RF signal; (b) one or more parameters of an RFsignal; and (c) data encoded in the RF signal. Such parameters include,but are not limited to the Received Signal Strength Indication (RSSI) orother RF signal strength, amplitude, phase, or other defined parameterof an RF signal provided (actively or passively). In particularembodiments, such parameters are compared with one or more pre-definedthreshold values to detect, for example, whether or not the parameterexceeds the threshold value(s). Data encoded in the RF signal includes,but is not limited to, data representing or associated with one or morecharacteristics of the cap 4, reservoir 1, base 2, infusion set 50 orthe base/reservoir/cap unit, or any combination thereof.

In particular embodiments, one or more RF detectable features 42 and orRF sensors 34, or both, are arranged such that the RF sensor detects theposition of the cap 4 relative to the infusion pump device 30 (e.g., fordetecting a proper connection of the cap 4 or the base/reservoir/capunit with the infusion pump device 30). For example, one or more RFshields, directional antennas, wave guides or other configurations maybe included in the cap 4, reservoir 1, or infusion pump device 30 (orall), to direct RF signals to or from RF detectable devices or sensors(or both). In particular embodiments, such RF shields, directionalantennas, wave guides or other configurations are arranged such that theRF sensor is able to detect the RF detectable device (or one or morepredefined parameters, data or both of a signal from the RF detectabledevice), when the RF sensor and the RF detectable device are in apredefined alignment, proximity (or both), such as when the cap 4 or thebase/reservoir/cap unit is properly connected with the infusion pumpdevice 30. In further embodiments, such RF shields, directionalantennas, wave guides or other configurations are arranged to inhibitdetection of the RF detectable device (or predefined parameter, data, orboth), when the cap or the base/reservoir/cap unit is not properlyconnected with the infusion pump device 30.

In other embodiments, one or more RF detectable features and sensorelements, are employed to detect one or more other characteristicsassociated with the cap 4 or the base/reservoir/cap unit or componentsthereof, in addition to or as an alternative to detecting properconnection with the infusion pump device 30. In various embodiments,such other characteristics include but are not limited tocharacteristics of the reservoir 1 (or its contents), infusion set 50,connection interface 40, or any combination thereof, as described abovewith respect to magnetic detection.

In those embodiments, each different characteristic may be associatedwith one or more detectable RF parameters such as, but not limited to:the existence of one or more RF detectable features or sensor elementson the cap 4, the location or pattern of locations of one or more RFdetectable features or sensor elements on the cap 4 (circumferential orlinearly location relative to the dimension of the axis A), the type ofRF detectable feature(s) or sensor devices(s) on the cap 4, the type orcontent of data stored by the RF detectable feature(s), the polarity,direction or orientation of the signal emitted by the RF detectablefeature(s), or the like. In particular embodiments, each differentpredefined characteristic of the reservoir 1, infusion set 50 orconnection interface 40, is associated (for example, on a one-to-onebasis) with a respectively different predefined detectable location,pattern of locations, type of RF detectable feature or sensor element,data type or content (code or other indicia) or other detectableparameter in the RF signal read from the RF detectable feature. In thoseembodiments, the processing electronics 62 is configured to determine acharacteristic of the reservoir 1, infusion set 50 or connectioninterface 40 from the signals received from the sensor element 34 or 42.

For example, the processing electronics 62 may be configured to compareinformation received from one or more RF sensor elements 34 with one ormore predefined, stored threshold, where each threshold is associatedwith a characteristic as described above. In other embodiments, theprocessing electronics 62 is configured to compare information receivedfrom one or more RF sensor elements 34 with values or information storedin a table or in another suitable data arrangement. The table or otherdata arrangement associates a plurality of different predefined RFdetectable device locations (or a plurality of different predefinedpatterns of RF detectable device locations on the cap) with acorresponding plurality of predefined characteristics. Alternatively orin addition, the table or other data arrangement associates a pluralityof different codes or other data receivable from RF detectable deviceswith a corresponding plurality of characteristics. The associations maybe, for example, but not limited to, a one-to-one correspondence of eachdifferent RF detectable device location, code or other data with adifferent characteristic, respectively. The table or other dataarrangement is stored in the electronic memory 66. Examplescharacteristics for RF detection embodiments include characteristics ofthe reservoir 1 (or its contents), the infusion set 50 connected to thecap 4, the connection interface 40, as described above with regard tomagnetic detection and incorporated herein by reference.

In particular embodiments, based on one or more of the parametersdetected from the signals received from the RF sensor, the processingelectronics 62 is further configured to determine correspondingcharacteristics and, based on those parameters or characteristics, doone or more of: determine operational settings for the infusion pumpdevice 30, provide signals to the drive device or other components ofthe infusion pump device 30, provide one or more alarm signals, andrecord data representing detected states or conditions of one or more ofthe cap 4, base/reservoir/cap unit, and infusion pump device 30, asdescribed above with regard to magnetic detection.

As described above, embodiments of the RF detectable feature 42 includeelectronics for storing data that is readable by an RF sensor element34. In particular embodiments, such data storage electronics areconfigured to be writable (to receive data and store received data). Insuch embodiments, an external writing device, such as, but not limitedto, a computer or processing device with a suitable data transmitter, isconfigured to write data onto the RF detectable feature. In particularembodiments, the RF detectable feature 42 includes multiple electronicstorage devices or one or more segmented storage devices, where one ormore of the storage devices or segments are writable and can receive andrecord data written thereto, as described above, while one or more otherstorage devices or segments store readable data (for example, recordedby a manufacturer or other authorized entity) but are not re-writable.Thus, for example, an RF detectable feature 42 may include a segmentedRFID tag having a first segment that stores information readable byelectronics in the infusion pump device 30, and a second segment thatstores additional information that is written onto the tag by ahealthcare provider or other authorized entity, or by electronics in theinfusion pump device 30.

In such embodiments, for example, a doctor or other health care providermay write and record information onto the RF detectable feature.Information written onto the RF detectable feature in that manner mayinclude, but is not limited to, data corresponding to thecharacteristics described above, instructions to be read by electronicsin the infusion pump device 30 for controlling an operation of theinfusion pump device 30 or for displaying information on a display ofthe infusions pump device 30, data corresponding to the user of theinfusion pump device 30 or a treatment associated with that user, orother data or combinations thereof.

In further embodiments, the infusion pump device 30 includes one or moredata writing devices for writing data onto an RF detectable feature 42,when the cap 4 or the base/reservoir/cap unit is properly connected withthe infusion pump device 30. In such embodiments, electronics 60 isconfigured to selectively write data (or read and write data) on the RFdetectable feature 42, in accordance with predefined, programmedinstructions. In one example embodiment, the electronics 60 includes oris connected with a sensor (not shown) for detecting one or moreparameters corresponding to the volume of infusion media dispensed bythe infusion pump device 30, and is configured to track the amount ofinfusion media dispensed from a reservoir 1 from a defined time upon orafter the reservoir 1 is installed in the reservoir receptacle 32, andwrite to record on the RF detectable feature 42 that tracked amount oran associated value representing a volume of infusion media dispensed orremaining in the reservoir 1.

Alternatively or in addition, in further embodiments the infusion pumpdevice 30 is configured to write to record other information on the RFdetectable feature 42, such as, but not limited to one or more of adate, time or geographic location at which the base/reservoir/cap unitor components thereof were installed in the infusion pump device 30. Infurther embodiments, such other information includes one or more ofoperational information or alarm conditions detected by the electronics60 during operation of the infusion pump device.

In further embodiments, such other information includes one or more of adate, time or geographic location at which infusion media was dispensed,an occlusion in the infusion set 50 was detected, an alarm condition wasdetected, or another predefined condition was detected or predefinedpump operation occurred. Thus, just as the processing electronics 62described above may be configured to detect, record (or both) thegeographic location of the infusion pump device 30, cap 4, orbase/reservoir/cap unit, or the time (or all) when a particularcharacteristic or event is detected, the processing electronics 62 mayalso or alternatively be configured to record such information onto theRF detectable feature 42.

In embodiments in which date or time is recorded, the electronics 60include or are associated with an appropriate clock or other source ofdate or time information. In embodiments in which geographic location isrecorded, the electronics 60 includes or is associated with suitablelocation detection electronics such as, but not limited to satelliteposition system electronics (for example, but not limited to a GPSsystem receiver), configured to detect a geographic location of theinfusion pump device 30.

In particular embodiments employing RF detection, the processingelectronics 62 is configured to determine operational settings for theinfusion pump device 30, provide alarm or control signals, record data,provide authentication operations, or perform other predefined tasksbase, at least in part, on detection of (or information provided by adetectable characteristic of) the RF detectable feature 42 in a mannersimilar to the manner described above with respect to magnet elements(s)as the detectable feature 42. Accordingly, the above description ofexample configurations and operations of processing electronics 62applies to the RF detectable feature 42. Thus, Parameters 1-N describedabove may be characteristics of the RF detectable feature 42, such as,but are not limited to the RSSI or other RF signal strength, amplitude,phase, data encoded in the RF signal or other defined parameter of an RFsignal.

Furthermore, in embodiments in which the presence or position (such asrotary position) of the cap 4 or the base/reservoir/cap unit relative tothe infusion pump device 30 is detected, an RF detection configurationcan provide a relatively precise position detection. For example, infurther examples of embodiments described above with respect to FIGS. 4Aand 4B, in which a plurality of elements 42 are arranged on the cap 4,at a corresponding plurality of different locations, spacedcircumferentially around or linearly along (or both) the axis A, theelements 42 are RF detectable devices, while the elements 34 are RFsensor devices. In other embodiments, the elements 42 are RF sensordevices (or both RF sensor devices and RF detectable devices), whileelements 34 are RF detectable devices (or both RF detectable devices andRF sensor devices).

In particular embodiments, RF detectable devices and RF sensor devicescan provide a relatively precise detection of proper or improperalignment or proximity (or both), of the base/reservoir/cap unitrelative to the reservoir receptacle 32, as described above with respectto FIGS. 4A and 4B. Also, in embodiments in which multiple RF sensors ormultiple RF detectable devices (or both) are employed on one or both ofthe cap 4 and infusion pump device 30, the multiple elements may bearranged to allow detection of various predefined states of the cap 4.Thus, in example embodiments, the multiple elements are arranged spacedapart around the circumference of the axis A to allow detection of therotational position (or movement) of the cap 4 around the axis A,relative to the infusion pump device 30. Alternatively or in addition,the multiple elements are arranged spaced apart in the axial dimension Aof the cap 4 to allow detection of the linear position (or movement) ofthe cap 4 along the axis A, relative to the infusion pump device 30. Inother embodiments, one or more elements are arranged to detect angulardifferences (or movement) between the axial dimension A of the cap andthe axial dimension of the reservoir receptacle 32. Accordingly, indifferent embodiments, the sensor element(s) provide one or more sensorsignals representing a rotational position of the cap 4, a linearposition of the cap 4, an angular position of the cap 4, or anycombination thereof.

RF detectable features and RF sensors can be configured, according toembodiments of the present invention, to provide a relatively preciseposition detection. Example configurations are described herein.However, other embodiments employ other suitable configurations thatprovide levels of precision appropriate for their context of use.

In particular embodiments, presence or position detection (or both) isaccomplished by configuring one or more RF sensor devices 34 (orelectronics connected to such sensor device(s)) to detect the signalstrength of one or more RF detectable feature 42. The signal strengthdetection may include a detection of the RSSI signal level. Inparticular embodiments, the electronics 60 connected to the sensor(s)are configured to compare a signal strength (such as RSSI signal level)detected by one or more sensor(s) with one or more predefined thresholdvalues. Such predefined threshold values may be set by a manufacturer orother entity associated with the infusion device pump 30, reservoir 1,cap 4 or other components described above, and stored in memory includedin or accessible by the electronics 60, such as memory 66. For example,in particular embodiments, the predefined threshold values includevalues that correspond to signal strength levels that are received byone or more RF sensor device(s) 34, when one or more RF detectablefeatures 42 are in a proper position or alignment (or both) with the oneor more RF sensor devices 34 (corresponding to when thebase/reservoir/cap unit is properly or fully received (or both) in theinfusion pump device 30).

In further particular embodiments, a single RF sensor device (forexample, represented by element 34 in FIGS. 4A and 4B) detects RFsignals from multiple RF detectable devices (for example, represented byelements 42A and 42B in FIGS. 4A and 4B). In such embodiments, the RFsensor device is connected with electronics 60 configured to determinethe signal strength (for example, RSSI signal level) of each sensor ofthe multiple sensors, for determining the position of the cap 4 relativeto the infusion pump device 30. Also in such embodiments, each of the RFdetectable device (e.g., elements 42A and 42B) may be configured toprovide a detectably different signal relative to each other of the RFdetectable devices. Accordingly, the electronics 60 may be configured todetermine which RF detectable device (e.g., element 42A or 42B) isassociated with each different detected signal, such that theelectronics associates a detected signal strength with each differentdetected signal (i.e., each different element 42A or 42B). Byassociating a detected signal strength for multiple RF detectabledevices (e.g., elements 42A or 42B), the electronics 60 can determinethe position of the cap 4 relative to the infusion pump device 30 withrelatively good precision. The electronics 60 may be configured toprocess information received from the sensor device(s) in any suitablemanner, such as, but not limited to, comparing detected signal strengthlevels of signals received from a plurality of RF detectable deviceswith a corresponding plurality of predefined threshold values, asdescribed above, for example, with respect to the process 150 in FIG. 6.However, other embodiments employ other suitable processing routines forevaluating signals received from a plurality of RF detectable devices.

In further embodiments, one or more RF detectable features or the one ormore RF sensors (or both) include an antenna configuration to enhancedetection capabilities or precision of the detection (for example,location or position detection precision). Thus, with reference toembodiments described above with respect to FIGS. 4A and 4B, in which aplurality of sensor devices or detectable devices (or both) are locatedin a spaced relationship around or along (or both) the axis A, infurther embodiments a plurality of antennas are similarly located in aspaced relationship around or along (or both) the axis A (e.g., on theinfusion pump device 30 or on the cap 4, or both).

In an example embodiment, one or more RF sensor devices or the RFdetectable features (or both) 34 or 42 described above include or areconnected with a plurality of antennas, where each antenna is located ata different position around the circumference or length (or both) of thedirection of the axis A. In embodiments in which one or more RF sensordevices are on the infusion pump device 30, a plurality of antennas maybe mounted in the infusion pump device 30 as part of or connected to theRF sensor device(s), and are arranged in a special array around or along(or both) the direction of the axis A. In embodiments in which the oneor more RF detectable features are on the cap 4 or other component ofthe base/reservoir/cap unit, a plurality of antennas may be mounted inthe cap 4 or other component of the base/reservoir/cap unit as part ofor connected to the RF detectable feature(s), and are arranged in aspatial array around or along (or both) the direction of the axis A.

For example, each antenna of (or connected to) a sensor device 34 isconfigured and oriented to communicate signals with (receive signalsfrom or transmit signals to, or both) one or more antennas of (orconnected to) an RF detectable feature 42, when that RF detectablefeature 42 is in a predefined position relative to the antenna (such as,but not limited to, a position directly adjacent the antenna), but doesnot sufficiently communicate signals with the RF detectable feature thatis not in the predefined position. In particular embodiments, one ormore antennas are arranged in locations that correspond to the positionof one or more of the RF detectable features when the base/reservoir capunit is fully or properly received within the infusion pump device 30.

Accordingly, electronics 60 connected with the RF sensor device 34 maybe configured to determine whether or not the base/reservoir/cap unit isfully received within or in a proper position relative to the infusionpump device 30 (or determine the position of the cap 4 relative to theinfusion pump device 30), based on signals received by one or moreantenna. In particular embodiments, the electronics 60 is configured toemploy information regarding signals received from a plurality ofantennas arranged around or along (or both) the direction of the axis A,to determine the position of the base/reservoir/cap unit (or cap 4)relative to the infusion pump device 30. In further embodiments, theelectronics 60 is configured to employ such information to determine thedirection or speed (or both) of rotation or other movement of thebase/reservoir/cap unit (or cap 4) relative to the infusion pump device30, for example, to evaluate whether the base/reservoir/cap unit (or cap4) is being moved in the proper or desired direction, to recordinformation corresponding to the direction or speed (or both) ofmovement, or a combination thereof.

In further embodiments, one or more antennas of sensor device(s) 34 areconfigured to receive signals from one or more antennas of the RFdetectable features 42, where the signal strength (such as, but notlimited to RSSI value) or other characteristic of the signal varies asthe relative position of the RF detectable device on the cap varies. Insuch embodiments, the electronics 60 is configured to employ signalstrength or other detected signal characteristic from one or a pluralityof antennas to determine the position of the base/reservoir/cap unit (orcap 4) relative to the infusion pump device 30. For example, the signalstrength (RSSI or other signal strength value) of a received signal canbe stronger as the relative positions of the antennas of the sensordevice and detectable device become closer (e.g., as the cap 4 orbase/reservoir/cap unit is moved toward a fully inserted position withinthe reservoir receptacle 32). Thus, the electronics 60 may be configuredto analyze detected signal strength from one or more sensor devices orone or more antennas (or both), such as, but not limited to comparingdetected signal strength with one or more preset thresholdscorresponding to predefined relative positions of the base/reservoir/capunit (or cap 4) and the infusion pump device 30. Other embodiments mayemploy other algorithms or routines for determining relative positionsfrom received signals.

Particular embodiments employ a plurality of antennas in a spacedarrangement as described above, and electronics 60 configured to analyzeRSSI values or other signal strength values for signals received by ortransmitted by (or both) the plurality antennas, to provide positiondetection or pattern recognition (to identify a detected pattern oflocations of the antennas from a plurality of predefined possiblepatterns), for example, with a high precision relative to a singleantenna arrangement. In those or other embodiments that employ aplurality of antennas, the antennas may be configured in a phased arrayconfiguration or other suitable configuration for providing a predefineddetectable signal directions or patterns.

In particular examples of embodiments that employ a plurality ofantennas or a plurality of sensor devices 34 (or both a plurality ofantennas and a plurality of sensor devices), the electronics 60 isconfigured to scan the array of sensors to selectively activate eachsensor or read a signal from each sensor (or both), in serial sequenceor other predefined sequence or a pseudo random sequence. For example,in particular embodiments, a plurality of antennas is arranged (on thecap 4, the infusion pump device 30, or both) at predefined locationsaround or along (or both) the circumference of the axis A, where eachantenna is configured to provide (or is connected with mutuallydifferent detectable devices or sensor devices configured to provide) adifferent detectable signal relative to each other antenna. Byconfiguring each antenna to provide a relatively narrow beam (narrowangle of transmission or reception beam or both), such as, but notlimited to a beam angle of about 1 to 3 degrees, and scanning theantennas, the electronics 60 may be configured to provide a relativelyprecise detection of the rotational or linear position of the cap 4 (orthe base/reservoir/cap unit) relative to the reservoir receptacle 32 ofthe infusion pump device 30. In other embodiments, other suitable beamangles may be employed, including beam angles of less than 1 degree orbeam angles greater than 3 degrees.

In those or other example embodiments that employ a plurality ofantennas or a plurality of sensor devices 34 (or both a plurality ofantennas and a plurality of sensor devices), the electronics 60 isconfigured to provide maximum ratio combining of received RF signals,for example, to improve signal-to-noise ratio. In such embodiments, thesignals received from a plurality of antennas in an array are combined,but the ratio of the combination is adjusted by the electronics 60,depending upon the strength of the signal. For example, the electronics60 may weight or increase the contribution of signals from antennas inthe array that are receiving stronger signals than antennas in the arraythat are receiving weaker signals (as determined by the electronics 60).

In particular embodiments, antennas may be calibrated (for example bythe factory that manufactures the cap, reservoir, base or infusion pumpdevice or by another authorized entity) for improved sensitivity andaccuracy. In further embodiments, detection sensitivity and precision isenhanced by employing any combination of two or more features describedabove including, but not limited to antenna beam forming configurations,antenna arrays of multiple antennas, different detectable parameters fordifferent antennas in an array, other transmission diversity fordifferent antennas in an array, maximum ratio combining, factorycalibration, or the like.

In examples of embodiments described above that employ one or moreantennas in or connected with one or more sensor devices 34, the sensorantenna(s) may be mounted in the infusion pump device 30, for example,adjacent the reservoir receptacle 32. In particular embodiments, thesensor antenna(s) is (are) located within the housing structure of theinfusion pump device 30, for example, by being embedded in or moldedwithin the plastic material that forms the housing structure or thestructure of the reservoir receptacle 32 (or both). In otherembodiments, the antenna(s) are attached to the housing or reservoirreceptacle structure of the infusion pump device 30 by an adhesive orconnective hardware (or both).

The size, position and/or orientation of an antenna can greatlyinfluence the strength of the signal and the detection of variousfeatures in an RF detectable feature, including but not limited to, anRFID. With this in mind, in certain embodiments, it can be beneficial toprovide as large an antenna area as possible and/or augment an antennain a cap 4. In particular embodiments, the RFID can include an antennaand/or electrical contacts that engage with an antenna formed on thereservoir. In further embodiments, the antenna is formed along the sideof the reservoir. In these embodiments, the antenna placed on thereservoir is oriented and/or provides increased size at a location moreideally suited to engage and work with the corresponding electronics onthe infusion pump device. In particular embodiments, more than oneantenna may be formed on the side of the reservoir. For instance, thismay be useful to assure alignment of the antenna after connection of thecap 4 to the reservoir and insertion and locking of the reservoir (orbase/reservoir/cap unit) in the infusion pump device housing. This maysimplify operation for the user, such that the user may more easilyattach the reservoir to the cap 4 without regard to the orientation ofthe cap 4 in relation to the reservoir. In particular embodiments, oneor more antenna is provided on the side of the reservoir, for example,by printing the antenna directly onto the side of the reservoir with asuitably conductive ink. In other embodiments, the antenna may beprovided on the reservoir in outer suitable manners including, but notlimited to molding the antenna into the reservoir, attached the antennato the reservoir by adhesive, applying the antenna to the reservoir as alabel or the like.

In other examples of embodiments described above that employ one or moreantennas in or connected with one or more RF detectable features 42, theantenna(s) may be mounted in the cap 4, base 2 or reservoir 1. In yetother embodiments, the antenna(s) are mounted in the infusion pumpdevice 30 (as described above), and are arranged to electrically connectwith one or more RF detectable features 42 on the cap 4, base 2 orreservoir 1, when the cap 4 (or the base/reservoir/cap unit) is properlyor fully received within the reservoir receptacle 32 of the infusionpump device 30. In such embodiments, the cap 4 (or other component ofthe base/reservoir/cap unit) includes a set of one or more electricallyconductive contacts that are included in or electrically connected tothe RF detectable feature(s) 42 (e.g., RFID tags or the like) and arearranged to engage a corresponding set of one or more electricallyconductive contacts on the infusion pump device 30, when the cap 4 (orbase/reservoir/cap unit) is properly and fully received within thereservoir receptacle 32 of the infusion pump device 30. In suchembodiments, the electrically conductive contacts on the cap 4 (orbase/reservoir/cap unit) are not in electrical communication with thecontacts on the infusion pump device 30, when the cap 4 (orbase/reservoir/cap unit) is not properly and fully received within thereservoir receptacle 32 of the infusion pump device 30. Accordingly, inthose embodiments, the RF detectable feature(s) 42 are electricallyconnected with one or more antenna(s), only when the cap 4 (orbase/reservoir/cap unit) is properly and fully received within thereservoir receptacle 32 of the infusion pump device 30.

In examples of embodiments described above that employ one or moreantennas mounted in or on the cap 4 (or another component of thebase/reservoir/cap unit), the antenna is arranged in sufficientproximity to a vent opening or port 24 on the cap 4 to contact water orother liquid that may come into contact with (or enter) the opening orport. In such embodiments, the antenna is configured to operate properlywhen dry (or out of contact with water or other liquid), but does notoperate (or operates in a detectably different manner) when in contactwith water or other liquid. Accordingly, in such embodiments, theantenna may operate as a moisture sensor that becomes inoperative oroperates in a detectably different manner, when in contact with water orother liquid (e.g., when the water or other liquid comes into contactwith or enters the opening or vent). For example, electronics 60 may beconfigured to provide an alarm signal, inhibit operation of one or morefunctions of the infusion pump device 30 (such as, but not limited to, afluid dispensing function), transmit a message or perform anotherpredefined task, or any combination thereof, when the antenna is notoperative, for example, due to the antenna being in contact with wateror other liquid.

In various embodiments described above, one or more RF detectablefeatures 42 are provided on the cap 4 (or other portion of thebase/reservoir/cap unit). In particular embodiments, one or more RFdetectable features 42 are provided on the plunger of a reservoir 1, andone or more RF detectors are provided on the infusion pump device 30, insufficient proximity to the reservoir receptacle 32, to interact withthe RF detectable feature 42 when the reservoir 1 is installed withinthe reservoir receptacle. For example, with reference to FIG. 16, atleast one RF detectable feature 42 is provided on a moveable plunger ofthe reservoir 1 (e.g., on the head 1 a of the reservoir plunger or theshaft 1 b of the reservoir plunger. In such embodiments, one or more RFsensors may be arranged in the infusion pump device 30 (e.g., within orin the vicinity of the reservoir receptacle 32), to detect linearpositions of the RF detectable feature 42 relative to the axis A, whenthe base/reservoir/cap unit is installed in the reservoir receptacle 32.Accordingly, based on the detected position of the RF detectable feature42, processing electronics (such as processing electronics 62) connectedto an electronic detection circuit associated with each coil 93 may beconfigured to detect the linear position of the plunger head 1 a and,thus, the amount of infusion media remaining in the reservoir 1.

In particular embodiments, the processing electronics is configured todetect the linear position of the plunger head 1 a and determine whetheror not the plunger head 1 a is in a filled position (corresponding to afilled or un-used reservoir 1), or whether or not the plunger head 1 ais in the last position from the previous use of the infusion pumpdevice 30. In such embodiments, the processing electronics may beconfigured to perform a predefined action in response to a determinationthat the plunger head is not in a filled position or is not in its lastposition (which may indicate that a used or re-used reservoir has beeninstalled in the infusion pump device). Such predefined action mayinclude, but is not limited to, inhibiting infusion media deliveryoperation of the infusion pump device 30, determining particularoperational settings for the infusion pump device 30, providing an alarmor control signals, recording data, providing authentication operations,or performing other predefined tasks.

In a further embodiment, the RF detectable feature 42 includes a passive(or active) RFID chip or other RF detectable feature that is providedwith a serial number or other code (unique or not unique among otherreservoirs 1). In such embodiments, when the reservoir 1 (orbase/reservoir/cap unit) is initially installed in the infusion pumpdevice 30 (or other suitable delivery device), or at a particular timeafter installation, electronics (such as electronics 60 in FIG. 5) readsthe serial number or code. In particular embodiments, the electronics 60are configured to determine whether or not the serial number or codecorresponds to that of reservoir 1 that was previously installed in theinfusion pump device 30 (or other delivery device), and perform apredefined action in the event that the correspondence is determined (ornot). In such embodiments, the electronics may be configured to store arecord of serial numbers or codes of reservoirs used over time in theinfusion pump device 30 (or other delivery device), and compare a newlyread serial number or code from a reservoir 1 with the pre-stored serialnumbers or codes to determine whether or not a match is found. A matchcan indicate a likelihood that the reservoir 1 had been previously used(or an attempt to re-use a previously used reservoir 1). In suchembodiments, the processing electronics may be configured to perform apredefined action in response to a determination that the serial numberor code read from the reservoir 1 matches a pre-stored serial number orcode (for a previously-used reservoir 1), including, but is not limitedto, inhibiting infusion media delivery operation of the infusion pumpdevice 30, determining particular operational settings for the infusionpump device 30, providing an alarm or control signals, recording data,providing authentication operations, or performing other predefinedtasks.

In embodiments as in FIG. 16 in which the RF detectable feature 42 islocated on the reservoir plunger, the RF detectable feature 42 may beeither a passive device or an active device. A passive device can beless costly and more durable than an active device. However, an activedevice can provide additional features as described herein.

In particular embodiments, the infusion pump device 30 (or otherdelivery device) is provided with an active RFID chip (or other activeRF device), while the plunger of the reservoir 1 is provided with apassive RFID chip (or other passive RF device). In such an arrangement,a magnetic field can exist between the passive chip on the reservoir 1and the active chip on the infusion pump device 30 (or other deliverdevice), where the magnitude of the magnetic field is dependent on therelative distance between the passive and active RF devices. In suchembodiments, the magnetic field increases as the RF device on thereservoir piston moves closer to the RF device on the infusion pumpdevice (or other delivery device), or decreases as the RF device on thereservoir piston moves further from the RF device on the infusion pumpdevice (or other delivery device).

Accordingly, in such embodiments, the sensor element 34 includes amagnetic field detector, to detect the magnetic field or changes in themagnetic field between the RF devices. Also in such embodiments,electronics (such as electronics 60 in FIG. 5 is configured to performone or more pre-defined actions, based on the magnetic field, includingthose described above. In particular embodiments, the electronics isconfigured to determine a volume of infusion media (level or amountremaining or used) for the reservoir 1, based on the detected magneticfield strength.

In further embodiments, volume is determined in other suitable manners.For example, in particular embodiments, as part of a filling operationin which the reservoir 1 is filled (partially or fully) at a fillingstation or filling device, information corresponding to the volume(amount filled) is written onto the RFID chip or other RF device on thereservoir plunger (or on another portion of the reservoir). Then, whenthe reservoir is installed in the infusion pump device (or otherdelivery device), electronics (such as electronics 60 in FIG. 5)provides a count of motor steps of the pump motor or other detection ofthe amount of infusion media dispensed after installation. Theelectronics further calculates a volume of infusion media remaining inthe reservoir 1 (for example, by subtracting the amount dispensed fromthe amount filled).

In particular embodiments, the electronics may be configured to displayvolume information (including, but not limited to the level or amount ofinfusion media remaining or used) on a user-perceptible display deviceon the infusion pump device 30. In embodiments in which the infusionpump device 30 (or other delivery device) is provided with an activeRFID chip (or other active RF device), additional information may bewritten to and read from the active chip or device, where suchinformation may include, but is not limited to volume information asdescribed above, or one or more serial numbers or codes as describedabove.

In further embodiments, one or more wireless or wired communicationdevices is provided on the infusion pump device 30 (or other deliverydevice) and is configured and controlled to transmit volume information(or other information corresponding to detected parameters or associatedcharacteristics) for display on another electronic device separate fromor located remote from the infusion pump device 30. In particularembodiments, the wireless communication device(s) are configured toconnect for communication on a communication network (such as, but notlimited to the Internet), with one or more pre-defined network connecteddevices. Such one or more pre-defined network connected devices may belocated at remote geographic locations relative to the infusion pumpdevice 30 (or other delivery device). In particular embodiments, suchnetwork connected devices include a server configured to receiveinformation from the infusion pump device 30 (or other delivery device)or from another network connected device (such as a cradle, usercomputer, or the like) that communicates with the infusion pump device30 (or other delivery device). Such information may include, but is notlimited to volume information, serial numbers or codes or otherinformation regarding the reservoir 1, cap 4, base/reservoir/cap unit orinfusion set as described above.

In such embodiments, the network connected server may be associated withan entity that records information, supplies associated products such asrefills or replacement parts, provides medical treatment or medicalinsurance to the user or the like. In one example, the network connectedserver is associated with the Carelink™ system of Medtronic Inc. Inother embodiments, the network connected server is one or more otherservers and associated entities. Accordingly, such information may beemployed by the server (or associated entity) to determine whether ornot (or when) to send refills, new or replacement reservoirs or othercomponents of the cap 4, base/reservoir/cap unit, or infusion set. Infurther embodiments, such information may be provided to the user'sdoctor or other medical treatment entity associated with the user (fortracking, diagnosing, adjusting treatment plans or other suitable uses).Thus, in such embodiments, refills or replacement components may be sentto users, automatically (without requiring the user to place an order),and usage information can be provided to the user's healthcare provider,insurance provider or other suitable entities, automatically.

In further embodiments, the network connected server is configured toprovide (and the infusion pump device 30 or other delivery device isconfigured to receive) information through the above-noted networkcommunication connection or other network connection. Such informationmay include, but is not limited to, instructions or recommendations forreplacing or refilling a reservoir 1, cap 4, base/reservoir/cap unit orinfusion set, messages or notices from healthcare providers, insurancecarriers or manufacturers, recall notices or the like. In particularembodiments, electronics (such as electronics 60) in the infusion pumpdevice 30 (or other delivery device) is configured to perform one ormore predefined actions (as discussed above) in response to receipt of apredefined instruction, notice or message.

In further embodiments, a predefined plurality (or lot) of reservoirs 1(or base/reservoir/cap units, infusion sets or components thereof) aresupplied to a user, where the RFID chips (or other RF devices) store oneor more serial numbers or codes (unique to each reservoir,base/reservoir/cap units, infusion sets or component thereof. In suchembodiments, electronics (such as electronics 60) in the infusion pumpdevice 30 (or other delivery device) may be configured to detect theserial numbers or codes of the reservoirs 1 (or base/reservoir/capunits, infusion sets or components thereof) when used in the infusionpump device 30 (or other delivery device). The detected serial numbersor codes are tracked (by the infusion pump device 30 or other deliverydevice, by a remote server as discussed above) to determine when apredefined number of the plurality (lot) of reservoirs 1 (orbase/reservoir/cap units, infusion sets or components thereof) has beenused, and to trigger an order (or re-order) of more reservoirs 1 (orbase/reservoir/cap units, infusion sets or components thereof).

In yet further embodiments, volume detection as described above can beemployed to detect a possible occlusion or blockage in the delivery pathbetween the infusion pump device 30 (or other delivery device) and theuser. In such embodiments, electronics (such as electronics 60) may beconfigured to perform volume detections as described above, to determinethe actual displacement or position of the reservoir plunger (forexample, by detection of the magnetic field strength as described above)and the motor count. In addition, the electronics 60 is configured todetermine whether the motor count corresponds to the actual displacementof the reservoir plunger. An actual displacement of the reservoirplunger that is less than the amount of displacement that is supposed tooccur with the detected number of motor counts may be an indication ofan occlusion or blockage in the delivery path. In particularembodiments, upon detection of a possible occlusion or blockage (e.g.,upon detection of the plunger displacement associated with the motorcount exceeding the actual displacement of the reservoir plunger by apredefined threshold amount), the electronics is configured to perform apredefined action, such as, but not limited to one or more of theactions discussed above.

In particular embodiments as described above, one (or all) of the cap 4,reservoir 1 and the infusion pump device 30 is provided with at leastone sensor element, and the other (or all) of the cap 4, reservoir 1 andthe infusion pump device 30 is provided with at least one detectablefeature that is detected by the sensor element(s) when the cap 4 (orbase/reservoir/cap unit) is properly coupled with the infusion pumpdevice 30. Certain embodiments as described above include one or moremagnetic detectable features and magnet detection sensors, or one ormore inductive members and inductive sensors. In other embodimentsdescribed above, each of the one or more detectable features 42 includesan RF detectable device or structure that can be detected by an RFsensor, and each sensor element 34 includes an RF sensor. In yet otherembodiments, the one or more detectable features 42 include anycombination of magnetic detectable devices, inductive detectable devicesand RF detectable devices, while the one or more sensor elements 34include any combination of one or more magnetic detection sensors,inductive sensors and RF sensors. Any of the embodiments describedherein with respect to use involving RFID also may be implemented withphysical wired connection, in lieu of a wireless RFID connection,between the reservoir 1, infusion set 50, and/or connection interface 40and the infusion pump device 30 (or other device(s)).

In further embodiments, one or more (or a plurality of) RF detectablefeatures 42 is included in a label (or smart label) that is adhered to,embedded in or otherwise attached to the reservoir 1, cap 4 or othercomponent of the base/reservoir/cap unit. In particular embodiments, thelabel includes an adhesive-backed substrate or other support layer onwhich an RFID tag or other RF detectable feature (including antenna) ismounted. The substrate may be made of any suitable material, such as aflexible sheet material made of plastic, silicone, paper or fiber board,or the like. In other embodiments, the substrate is made of othersuitable material such as, but not limited to other flexible materialsor a rigid or semi-rigid material made of metal, plastic, ceramic,composite material or the like. In particular embodiments, the label canbe directly adhered to the cap 4, reservoir 1, or other component of thebase/reservoir/cap unit by an adhesive material on a back surface of thesubstrate. In other embodiments, the label is attached to the reservoir1, cap 4 or other component of the base/reservoir/cap unit with anothersuitable attachment mechanism such as, but not limited to crimping,welding, magnetic connection, screws, bolts, clamps or other mechanicalconnection devices. The RFID device, and parts thereof, may span acrossmultiple components and be part of, e.g., the reservoir 1, infusion set50, tubing 52, connection interface 40, etc., or wholly integrated intoany single one of the above-mentioned components.

In yet further embodiments, the label is configured in the form of adata strip having a lengthwise dimension and one or more (or a pluralityof) RF detectable features along its lengthwise dimension. In otherembodiments, the data strip has one or more (or a plurality of) othertypes of detectable features 42 as described herein (such as, but notlimited to magnetic, inductive, optical, and mechanical detectablefeatures) as an alternative or in addition to one or more RF detectablefeatures 42 along its lengthwise dimension. In particular embodiments,the detectable features 42 include one or more optically detectablefeatures in a pattern, such as, but not limited to a bar code pattern orother optically detectable pattern of elements having dark and light (orlow or high reflective) characteristics.

In particular embodiments, the data strip is configured to extend aroundthe cap 4, reservoir 1, or other component of the base/reservoir/capunit (around the circumference or axis A), such that the one or more (orplurality of) detectable features 42 extend around the cap 4, reservoir1, or other component of the base/reservoir/cap unit (around thecircumference or axis A). In such embodiments, one or more sensors 34are mounted in or to the infusion pump device 30. The sensor(s) 34 aresupported at one or more fixed locations on the infusion pump device 30for detecting the detectable feature(s) on the data strip, when the cap4 (or base/reservoir/cap unit) is installed in the reservoir receptacle32 of the infusion pump device 30.

In particular embodiments, one or more sensor(s) 34 are arranged aroundthe circumference of the reservoir receptacle 32 and axis A fordetection of one or more detectable features 42 on the label (or datastrip). In such embodiments, the sensor(s) 34 and associated electronics(such as electronics 60 in FIG. 5) are configured to detect one or bothof the presence or position (such as rotary position) of the cap 4 orthe base/reservoir/cap unit relative to the infusion pump device 30,where an array of detectable features 42 on a label (or data strip) canprovide a relatively precise position detection. For example, a label ordata strip can be configured to provide a plurality of detectableelements arranged around the cap 4, reservoir 1, or other component ofthe base/reservoir/cap unit, at a corresponding plurality of differentlocations, spaced circumferentially around or linearly along (or both)the axis A. In such embodiments, one or more sensor(s) 34 may bearranged around the reservoir receptacle 32 and axis A as describedabove with respect to FIGS. 4A and 4B.

In particular embodiments, an array of detectable features 42 on a labelor data strip as described above can provide a relatively precisedetection of proper or improper alignment or proximity (or both), of thecap 4, reservoir 1, or other component of the base/reservoir/cap unitrelative to the reservoir receptacle 32, as described with respect toFIGS. 4A and 4B. Also, in particular embodiments multiple detectablefeatures may be arranged to allow detection of various predefined statesof the cap 4, reservoir 1, or other component of the base/reservoir/capunit.

Thus, in example embodiments in which the base/reservoir/cap unit isinstalled in the reservoir receptacle 32 by rotating thebase/reservoir/cap unit around the axis A while inserting thebase/reservoir cap unit into the reservoir receptacle 32, rotationalposition detection or linear position detection (or both) can beaccomplished. In such embodiments, multiple detectable elements 42 arearranged on the label or data strip and spaced apart from each otheraround the circumference of the axis A, to allow detection of therotational position (or movement) of the cap 4, reservoir 1, or othercomponent of the base/reservoir/cap unit around the axis A, relative tothe infusion pump device 30. Alternatively or in addition, the multipleelements are arranged spaced apart in the axial dimension A of the cap4, reservoir 1, or other component of the base/reservoir/cap unit toallow detection of the linear position (or movement) of the cap 4,reservoir 1, or other component of the base/reservoir/cap unit along theaxis A, relative to the infusion pump device 30. Accordingly, indifferent embodiments, the sensor element(s) 34 provide one or moresensor signals representing a rotational position of the cap 4,reservoir 1, or other component of the base/reservoir/cap unit, a linearposition of the cap 4, reservoir 1, or other component of thebase/reservoir/cap unit, or a combination thereof.

In particular embodiments, each detectable feature comprises an RFID tagor other RF detectable feature or other type of detectable feature 42 asdescribed herein (such as, but not limited to magnetic, inductive,optical, and mechanical detectable features) and is configured torepresent a data value that is detectable by one or more (or each of aplurality of) sensor elements 34. In particular embodiments, thedetectable features are printed in magnetically detectable ink,polarized or optically detectable ink, or other materials that can bereadily applied to a label or data strip. In other embodiments, thedetectable features are discrete elements that are attached to the labelor data strip by adhesive or other suitable attachment mechanism. Inparticular embodiments, the detectable features (or the label or datastrip) is made to be transparent or partially transparent, or colored tobe invisible, partially invisible or camouflaged on the cap 4, reservoir1 or other component of the base/reservoir/cap unit. In otherembodiments, the detectable features (or the label or data strip) areconfigured to be viewable.

In further embodiments, the data value represented by each detectablefeature 42 has one of two detectable states (for example, one of “0” or“1”, or one of positive or negative, or one of two other pre-definedvalues). In such embodiments, a label or data strip having a pluralityof detectable features can be configured as a data strip having aplurality of detectable features 42, where each detectable featurerepresents one of the two detectable states (e.g., a “0” or a “1”). Inparticular examples of such embodiments, a plurality of the detectablefeatures on the label or data strip pass adjacent to (and are read inseries by) one or more sensor elements (34) fixed to the infusion pumpdevice 30, as the cap 4, reservoir 1, or other component of thebase/reservoir/cap unit is inserted into the reservoir receptacle 32 orrotated relative to the reservoir receptacle 32 (or both).

In particular embodiments, the detectable states of the detectablefeatures 42 on the label or data strip represent particular informationassociated with the cap 4, reservoir 1, or other component of thebase/reservoir/cap unit or infusion set connected thereto, such as, butnot limited to, the characteristics of the cap 4, reservoir 1, or othercomponent of the base/reservoir/cap unit or infusion set describedabove. Thus, for example, each possible characteristic can be associatedwith (on a one-to-one basis or other pre-defined association) aparticular pattern of detectable features 42 or a particular pattern ofdetectable values (such as, but not limited to “0's” and “1's”) of thedetectable features 42 on the label or data strip. In such embodiments,such associations may be stored in a memory (such as memory 66 in FIG.5), for use by processing electronics (such as processing electronics62) performing a process (such as process 150 in FIG. 6) to determine acharacteristic of the cap 4, reservoir 1, or other component of thebase/reservoir/cap unit or infusion set, based on the pattern ofdetectable features or values detected by the sensor element(s) 34, andperform a predefined action based on or using the characteristic.

In further embodiments, a label or data strip is configured with two ormore tracks of detectable features 42, where each track includes aseries of two or more detectable features arranged in a linear row (orother predefined pattern). In one example, the two or more tracks areparallel to each other, such that two or more linear rows (or otherpatterns) of detectable features are arranged around the circumferenceof the cap 4, reservoir 1, or other component of the base/reservoir/capunit. In such embodiments, each of the plural track includes a pluralityof detectable features 42 that have a pattern or values (or both)representing one or more characteristics of the cap 4, reservoir 1, orother component of the base/reservoir/cap unit or infusion set.

In particular embodiments, one or more of the plural tracks is a clocktrack that provides a series of detectable elements evenly spaced (orspaced at predefined intervals) along the track. In particularembodiments, the detectable elements in the clock track are arranged inalternating fashion (such as, but not limited to, alternating “0's” and“1's”). In such embodiments, processing electronics (such as processingelectronics 62 in FIG. 5) may be configured to detect the alternating(or other predefined pattern) of detectable values to determine a timingof motion (such as timing of rotational motion or linear motion) of thecap 4, reservoir 1, or other component of the base/reservoir/cap unit orinfusion set, relative to the reservoir receptacle 32 (or axis A), asthe cap 4, reservoir 1, or other component of the base/reservoir/capunit is installed in the reservoir receptacle 32. By determining thetiming of the detection of the detectable features 32, the speed ofrotation or speed of insertion, as well as the rotational position andinsertion position of the reservoir 1, cap 4 or base/reservoir/cap unitcan be determined by the processing electronics (as a function of thetiming of detection of the detectable features and the spacing betweendetectable features 42 in the timing track)

In particular embodiments, the label or data strip includes a predefineddetectable feature 42 having a predefined detectable value, or apredefined pattern of detectable features 42, for example, at the end oftrack of detectable features. In such embodiments, the predefineddetectable feature, value or pattern is arranged at a locationcorresponding to a fully installed or final position state of the cap 4,reservoir 1, or other component of the base/reservoir/cap unit in thereservoir receptacle 32. In other words, the predefined detectablefeature, value or pattern is arranged at a location on the track toalign with and be read by one or more sensor element(s) 34, when the cap4, reservoir 1, or other component of the base/reservoir/cap unit is ina proper, fully installed position within the reservoir receptacle 32(but not read, when the cap, reservoir or base/reservoir/cap unit is notproperly or fully installed).

d. Mechanical Detection

Certain embodiments as described above include one or more magnetic, RF,or inductively detectable features and one or more magnet, RF orinductive detection sensors, and other embodiments include combinationsthereof. In yet other embodiments, a mechanical detection is employed,where the one or more detectable features 42 include a mechanicallydetectable feature while the one or more sensor elements 34 include amechanism that mechanically interacts with the mechanically detectablefeature(s). In yet other embodiments, the one or more detectablefeatures 42 include a combination of two or more of a magneticallydetectable feature, an inductively detectable feature, an RF detectablefeature and a mechanically detectable feature, while the one or moresensor elements 34 include a combination of two or more of a magneticsensor, an inductive sensor, an RF sensor and a mechanical sensor.

Accordingly, arrangements and configurations of magnetic detectablefeatures and sensors, inductively detectable features and inductivesensors and RF detectable features and sensors (as the detectablefeatures and sensors 34 and 42) as described above and shown in FIGS.1-16 are incorporated herein by reference to apply to embodimentsemploying mechanically detectable features and associated mechanicalsensors, as the sensor elements and detectable features 34 and 42. Anysuitable mechanical or electromechanical sensor and detectable featuremay be employed as the one or more sensor elements and detectablefeatures 34 and 42 for mechanical detection of the presence or position(or both) or other characteristic of the cap 4 (or base/reservoir/capunit).

One example embodiment of a mechanical detection configuration isdescribed with reference to FIG. 17. The drawing in FIG. 17 shows apartial, cross-section view of a portion of an infusion pump device 30,with a reservoir 1 and cap 4 of a base/reservoir/cap unit (only aportion of which is in view) installed within the reservoir receptacle32. The infusion pump device 30 includes a housing 33 that includes thereservoir receptacle 32 and that contains components such as a drivedevice, and one or more sensor device(s) or detectable devices (or both)and associated electronics, as described herein. The drawing in FIG. 18shows an enlarged partial cross-section view of a similar portion of theinfusion pump device 30, but with the reservoir receptacle 32 free ofthe reservoir 1 and cap 4 (base/reservoir/cap unit.)

In embodiments in which the one or more sensor element(s) or detectablefeatures are configured for mechanical detection, either the infusionpump device 30 or the cap 4 (or other component of thebase/reservoir/cap unit), or both, holds a sensor device that includes amechanically moveable member or actuator. The mechanically moveablemember (actuator) is arranged to engage an engagement portion of theother of the infusion pump device 30 or the cap 4 (or other component ofthe base/reservoir/cap unit) and to be moved from a first position to asecond position, when the cap 4 (or base/reservoir/cap unit) is beingproperly and fully received within the reservoir receptacle 32 of theinfusion pump device 30. In such embodiments, the mechanically moveablemember engages the engagement portion and is moved from the firstposition to the second position, as a result of a manual movement of thecap 4 (or base/reservoir/cap unit) into the reservoir receptacle 32 andto a proper and fully received position within the reservoir receptacle32.

The mechanically moveable member is arranged to engage and activate anelectrical switch, when the mechanically moveable member is moved to thesecond position, but is arranged to disengage and not activate theelectrical switch when in the first position. Accordingly, a manualmovement of the cap 4 (or base/reservoir/cap unit) into the reservoirreceptacle 32 and to a proper and fully received position within thereservoir receptacle 32 causes the mechanically moveable member to moveto the second position and engage and activate the electrical switch.The electrical switch is connected to electronics (such as electronics60 discussed above) for detecting whether or not the switch isactivated. Accordingly, by detecting the activation state of theelectrical switch, the electronics determines whether or not the cap 4(or base/reservoir/cap unit) is properly and fully received within thereservoir receptacle 32.

In the embodiment of FIGS. 17 and 18, a mechanically moveable member 70is supported for movement within a channel 72 located in the infusionpump device 30. The moveable member 70 in FIGS. 17 and 18 has agenerally elongated shaft or cylinder shape and is made of a suitablyrigid material that holds its shape during normal operation such as, butnot limited to plastic, metal, ceramic, wood, composite material, or anycombination thereof. In other embodiments, the moveable member 70 mayhave any other suitable shape or form.

The channel 72 may be formed within the structure of the housing 33 ofthe infusion pump device 30 or within a further structure located withinthe housing 33. A first end of the channel 72 is open into the reservoirreceptacle 32. A second end of the channel 72 is open into anotherportion of the interior of the housing 33 of the infusion pump device30. In the illustrated embodiment, the channel 72 is linear along alongitudinal dimension (horizontal dimension in FIGS. 17 and 18), andthe moveable member 70 has a corresponding longitudinal shape thatextends along the longitudinal dimension of the channel 72. In otherembodiments, the channel 72 (and the moveable member 70) may havecorrespondingly curved shapes or other suitable shapes that allow themoveable member 70 to move between first and second positions within thechannel 72.

As shown in FIG. 17, the moveable member 70 has a first end 74 (the endon the right side of the moveable member 70 in FIG. 17) that is arrangedto engage an electrical switch 76. The moveable member 70 has a secondend 78 (the end on the left side of the moveable member 70 in FIG. 17)that is arranged to be engaged by an engagement portion 80 of the cap 4(or other component of the base/reservoir/cap unit) when the cap 4 (orbase/reservoir/cap unit) is properly and fully received within thereservoir receptacle 32.

More specifically, the engagement portion 80 of the cap 4 (or othercomponent of the base/reservoir/cap unit) has a surface that comes intocontact with and engages a surface of the second end 78 of the moveablemember 70, as the cap 4 (or the base/reservoir/cap unit) is manuallyinserted and moved into a proper and fully inserted position within thereservoir receptacle 32 of the infusion pump device 30.

As the cap 4 (or the base/reservoir/cap unit) is manually moved towardthe proper and fully inserted position within the reservoir receptacle32, the engagement portion 80 engages the second end 78 of the moveablemember 70. Then, further movement of the cap 4 (or thebase/reservoir/cap unit) toward the a proper and fully inserted positioncauses the engagement portion 80 to push the second end 78 of themoveable member 70 and move the moveable member 70 from a first position(shown in FIG. 18) to a second position (shown in FIG. 17). The movementof the moveable member 70 from the first position (FIG. 18) to thesecond position (FIG. 17) causes the first end 74 of the moveable member70 to push against and activate the electrical switch 76. In contrast,when the moveable member 70 is in the first position (FIG. 18), thefirst end 74 of the moveable member 70 is out of contact with the switch76 (or is in contact with the switch 76, but does not apply sufficientmechanical force to activate the switch 76). Accordingly, the switch 76is activated by the moveable member 70, when the cap 4 (or thebase/reservoir/cap unit) is in the proper and fully inserted positionwithin the reservoir receptacle 32, but is not activated by the moveablemember 70, when the cap 4 (or the base/reservoir/cap unit) is not in aproper and fully inserted position within the reservoir receptacle 32.In further embodiments, the first end 74 of the moveable member 70 isconnected to or arranged adjacent a linkage structure that communicatesmovement of the first end 74 to the switch 76.

In particular embodiments, the second end 78 of the moveable member 70extends a small distance into the reservoir receptacle 32, when themoveable member 70 is in the first position (FIG. 18). In that position,the second end 78 of the moveable member 70 is arranged in a location tobe contacted by the engagement portion 80 of the cap 4 (or thebase/reservoir/cap unit) as the cap 4 (or the base/reservoir/cap unit)is moved toward a proper and fully inserted position within thereservoir receptacle 32. In particular embodiments, the second end 78 ofthe moveable member 70 is rounded, tapered or provided with anothersuitable shape that helps to transfer the linear motion of the cap 4 orthe base/reservoir/cap unit (e.g., downward motion in the direction ofthe reservoir receptacle 32 in FIGS. 17 and 18) to linear motion of themoveable member 70 along the longitudinal dimension of the channel 72,as the cap 4 (or the base/reservoir/cap unit) is moved toward a properand fully inserted position within the reservoir receptacle 32.

In particular embodiments, the second end 78 of the moveable member 70extends into the channel of the reservoir receptacle 32 by a distancesufficient to contact an outer surface of the cap 4 (or thebase/reservoir/cap unit) and ride along that outer surface (allow thatouter surface to slide over the second end 78 of the moveable member 70)without moving to the second position and, thus, without actuating theswitch 76, as the cap 4 (or the base/reservoir/cap unit) is manuallyinserted into the reservoir receptacle 32 and rotated toward a properposition. When the cap 4 (or base/reservoir/cap unit) is properly andfully received (inserted and rotated into proper position) in thereservoir receptacle 32, the engagement portion 80 on the cap 4 (or thebase/reservoir/cap unit) comes into engagement with the second end 78 ofthe moveable member 70 and imparts a sufficient force onto the moveablemember 70 to push the first end 74 of the moveable member 70 against theswitch 76 with enough force to activate the switch 76.

In particular embodiments, the second end 78 of the moveable member 70(or the entire moveable member 70) is made of a material that issufficiently compliant, flexible and resilient to be compressed at leastat the second end 78 by the engagement portion 80, when the second end78 of the moveable member 70 is contacted by the engagement portion 80.For example, the material may be sufficiently compliant and flexible toaccommodate for different cap 4 sizes or for manufacturing tolerances(or both). Thus, the second end 78 of the moveable member 70 may extendinto the reservoir receptacle 32 by a distance sufficient to contact acap 4 having any size outer diameter (within a predefined range), bycompressing sufficiently to accommodate larger diameters within thatrange.

In particular embodiments, the moveable member 70 is sufficientlycompliant, flexible and resilient to transfer at least a portion of thecompression force on the second end 78, through the moveable member 70,to produce a resulting expansion or outward bulging of the first end 74by an amount that applies a force on the switch 76 sufficient toactivate the switch 76. Thereafter, when the engagement portion 80 ismoved away from the second end 78 of the moveable member 70 (forexample, when the cap 4 or base/reservoir/cap unit is being withdrawnfrom the reservoir receptacle 32), the second end 78 of the moveablemember 70 is no longer compressed and, due to the natural resilience ofthe material of the moveable member 70, the first end 74 returns to astate in which it is not imparting an activation force on the switch 76,to cause the switch to change state (for example, turn off).

Thus, in certain embodiments, the moveable member 70 may be arranged tomove from the first position to the second position, without physicallyshifting toward the switch 76 other than by the action of compressing atthe second end 78 to cause the first end 74 to bulge out or expandtoward or against the switch 76, as described above. In suchembodiments, the moveable member 70 may be configured to avoid orminimize movement of seal structures 86 (described further, below)during movement of the moveable member 70, thus reducing wear on theseal structures 86 and improving sealing functions. In otherembodiments, the entire moveable member 70 is also shifted toward theswitch 76 while the first end 74 is expanded to activate the switch 76,when the second end 78 of the moveable member 70 is contacted by theengagement portion 80. In yet other embodiments, the moveable member 70is not compressed or expanded, but, instead, is shifted withoutexpansion toward the switch 76, when the second end 78 of the moveablemember 70 is contacted by the engagement portion 80.

In particular embodiments in which the moveable member 70 shifts towardthe switch 76 when moving from the first position to the secondposition, the moveable member 70 includes or is engaged by a bias member82 that imparts a bias force on the moveable member 70 to bias themoveable member 70 toward the first position (FIG. 18 position). Thebias member 82 may be any suitable structure or device that imparts aforce on the moveable member 70 in the direction of the first position,such as, but not limited to a coil spring, a leaf spring, other springconfiguration, a magnet, balloon or other pressurized expandablecontainer, or the like. In the drawings of FIG. 18, a coil spring isshown as one example of a bias member 82.

In such embodiments, the moveable member 70 includes a protrusion,extension or other structure that provides a stop surface for stoppingfurther motion of the moveable member 70 in the direction of the firstposition, when the moveable member 70 reaches the first position. In theembodiment of FIGS. 17 and 18, the moveable member 70 includes aprotruding shoulder 84 that provides the stop surface. In theillustrated embodiment, the protruding shoulder 84 is arranged outsideof the channel 72 and adjacent the second end of the channel 72. Theprotruding shoulder 84 is configured to be larger (wider) than adimension (e.g., the width dimension) of the channel 72, so that theprotruding shoulder is not able to pass through the channel.Accordingly, the protruding shoulder 84 provides a stop surface (e.g., asurface of the shoulder 84) that engages a surface of the structure inwhich the channel 72 is located, when the moveable member 70 is in thefirst position (FIG. 18). However, the protruding shoulder 84 is spacedapart from that surface of the structure in which the channel 72 islocated, when the moveable member 70 is in the second position (FIG.17), or is between the first and second positions.

In particular embodiments, one or more seals or other features areprovided for inhibiting the passage of moisture, liquid or other fluidthrough the channel 72, for example, in the event that moisture, liquidor other fluid enters the reservoir receptacle 32. Thus, the passage ofmoisture, liquid or other fluid from the reservoir receptacle 32 toother areas within the infusion pump housing 33 can be inhibited, forexample, in the event that the infusion pump device 30 is exposed tomoisture, liquid or other fluid (such as, for example, rain, pool water,shower water, or the like).

In the embodiment of FIGS. 17 and 18, the moveable member 70 is providedwith one or more (two shown in the drawings) seal structures 86, forsealing against the interior surface of the channel 72. In theillustrated embodiment, two seal structures 86 are provided on themoveable member 70. In other embodiments, a single one or more than twoseal structures 86 may be employed. In particular embodiments, each sealstructure 86 includes a protruding extension or ring of material aroundthe movable member 70 (e.g., around the circumference of the shaft orcylindrical structure of the moveable member 70). In certainembodiments, one or more seal structures 86 are formed of the samematerial as the moveable member 70 and is either formed as part of themoveable member 70 (e.g., molded or machined, or the like, with themoveable member 70) or formed separately and attached to the moveablemember 70. In certain embodiments, one or more seal structures 86 arecomposed of an O-ring made of the same material as the moveable member.In other embodiments, one or more seal structures 86 are composed of anO-ring made of a different material as the moveable member, such as aflexible, compliant material suitable for sealing functions, including,but not limited to a rubber, plastic or other compliant material.

The switch 76 may be any suitable electrical switch that has a firststate (not activated) and a second state (activated), and that isconfigured to change states when pushed or contacted by the moveablemember 70. In one embodiment, the switch 76 is a push-button type switchthat has a button structure that can be pushed (e.g., by the moveablemember 70) to change the state of the switch. In other embodiments,other suitable switch configurations may be employed. In certainembodiments, the moveable member 70 can form part of the electricalswitch, where the moveable member 70 is made of an electricallyconductive material (or includes an electrically conductive material atthe first end 74) and makes electrical contact with one or moreelectrodes on the switch 76 to change the state of the switch, when themoveable member 70 is in the second position (e.g., FIG. 17 position).

In the embodiment of FIG. 17, the switch 76 is attached to and supportedby a circuit board 90 (such as a printed circuit board or otherstructure that supports electronics 60 or other electronics associatedwith the switch). The switch 76 and circuit board 90 may be held withina confined volume in the housing 33 of the infusion pump device 30. Inparticular embodiments, one or more bias members 92 (such as springs,pogo pin structures, flexible and resilient members or the like) arearranged at one or more locations adjacent the circuit board 90 orswitch 76 (or both), to impart a bias force onto the circuit board 90and switch 76 to help locate or maintain the circuit board 90 and switch76 in a predefined position, with sufficient precision. In this manner,the position of the switch 76 can be sufficiently defined andmaintained, for example, for proper alignment with the moveable member70, to accommodate for manufacturing tolerances, or both.

The embodiment of FIGS. 17 and 18 includes one sensor element (composedof a moveable member 70 and switch 76). In other embodiments, two ormore (a plurality of) sensor elements, each composed of a respectivemoveable member 70 and associated switch 76, arranged at differentrespective predefined locations around or along the reservoir receptacle32 of the infusion pump device 30. In particular embodiments, one ormore moveable members 70 and associated switches 76 are arranged todetect the position of the cap 4 relative to the infusion pump device 30(e.g., for detecting a proper connection of the cap 4 or thebase/reservoir/cap unit with the infusion pump device 30).

In other embodiments, one or more moveable members 70 and associatedswitches 76 are employed to detect one or more other characteristicsassociated with the cap 4 or the base/reservoir/cap unit or componentsthereof, in addition to or as an alternative to detecting properconnection with the infusion pump device 30. In various embodiments,such other characteristics include but are not limited tocharacteristics of the reservoir 1 (or its contents), infusion set 50,connection interface 40, or any combination thereof, as described abovewith respect to magnetic detection or RF detection.

In those embodiments, a particular characteristic may be associated withone or more mechanical parameters such as, but not limited to: theexistence of one or more predefined engagement portions 80 on the cap 4,or the location or pattern of locations of one or more predefinedengagement portions 80 on the cap 4 (circumferential or linearlylocation relative to the dimension of the axis A), the shape or otherparameter of the predefined engagement portion 80, or any combinationthereof. In particular embodiments, each different predefinedcharacteristic of the reservoir 1, infusion set 50 or connectioninterface 40, is associated (for example, on a one-to-one basis) with arespectively different predefined location, pattern of locations, orother detectable parameter of the engagement portion 80. In thoseembodiments, the processing electronics 62 is configured to determine acharacteristic of the reservoir 1, infusion set 50 or connectioninterface 40 from the signals received from the one or more switch(es)76.

For example, the processing electronics 62 may be configured to compareinformation received from one or more switches 76 with informationstored in a table or in another suitable data arrangement. The table orother data arrangement is stored in the electronic memory 66. The tableor other data arrangement associates a plurality of different predefinedengagement portion 80 locations (or a plurality of different predefinedpatterns of engagement portion 80 locations on the cap) with acorresponding plurality of predefined characteristics, as describedabove with respect to the magnetic, inductive and RF detectionembodiments and incorporated herein by reference.

In particular embodiments, based on one or more of the parametersdetected from the signals received from the one or more switches 76, theprocessing electronics 62 is further configured to determinecorresponding characteristics and, based on those characteristics, doone or more of: determine operational settings for the infusion pumpdevice 30, provide signals to the drive device or other components ofthe infusion pump device 30, provide one or more alarm signals, andrecord data representing detected states or conditions of one or more ofthe cap 4, base/reservoir/cap unit, and infusion pump device 30, asdescribed above with regard to magnetic detection, inductive detection,and RF detection embodiments.

In further embodiments, one or more wireless or wired communicationdevices is provided on the infusion pump device 30 (or other deliverydevice) and is configured and controlled to transmit volume information(or other information corresponding to detected parameters of the RFdetectable feature, or associated characteristics) for display onanother electronic device separate from or located remote from theinfusion pump device 30. In particular embodiments, the wirelesscommunication device(s) are configured to connect for communication on acommunication network (such as, but not limited to the Internet), withone or more pre-defined network connected devices. Such one or morepre-defined network connected devices may be located at remotegeographic locations relative to the infusion pump device 30 (or otherdelivery device). In particular embodiments, such network connecteddevices include a server configured to receive information from theinfusion pump device 30 (or other delivery device) or from anothernetwork connected device (such as a cradle, user computer, or the like)that communicates with the infusion pump device 30 (or other deliverydevice). Such information may include, but is not limited to volumeinformation, serial numbers or codes or other information regarding thereservoir 1, cap 4, base/reservoir/cap unit or infusion set as describedabove.

In such embodiments, the network connected server may be associated withan entity that records information, supplies associated products such asrefills or replacement parts, provides medical treatment or medicalinsurance to the user or the like. In one example, the network connectedserver is associated with the Carelink™ system of Medtronic Inc. Inother embodiments, the network connected server is one or more otherservers and associated entities. Accordingly, such information may beemployed by the server (or associated entity) to determine whether ornot (or when) to send refills, new or replacement reservoirs or othercomponents of the cap 4, base/reservoir/cap unit, or infusion set. Infurther embodiments, such information may be provided to the user'sdoctor or other medical treatment entity associated with the user (fortracking, diagnosing, adjusting treatment plans or other suitable uses).Thus, in such embodiments, refills or replacement components may be sentto users, automatically (without requiring the user to place an order),and usage information can be provided to the user's healthcare provider,insurance provider or other suitable entities, automatically.

In further embodiments, the network connected server is configured toprovide (and the infusion pump device 30 or other delivery device isconfigured to receive) information through the above-noted networkcommunication connection or other network connection. Such informationmay include, but is not limited to, instructions or recommendations forreplacing or refilling a reservoir 1, cap 4, base/reservoir/cap unit orinfusion set, messages or notices from healthcare providers, insurancecarriers or manufacturers, recall notices or the like. In particularembodiments, electronics (such as electronics 60) in the infusion pumpdevice 30 (or other delivery device) is configured to perform one ormore predefined actions (as discussed above) in response to receipt of apredefined instruction, notice or message.

In particular embodiments, the engagement portion 80 may be a raised orpredefined surface, projection, bump, rib, gradual rise, detent,aperture, groove or other mechanically detectable feature provided inany suitable location on the cap 4 (or other component of thebase/reservoir/cap unit) for contacting the second end 78 of themoveable member 70, when the cap 4 (or the base/reservoir/cap unit) ismanually inserted and moved into the a proper and fully insertedposition within the reservoir receptacle 32 of the infusion pump device30. The engagement portion 80 may be made sufficiently small or of asize or shape (or both) to align with and engage the moveable member 70only when the cap 4 (or base/reservoir/cap unit) is fully and properlyreceived within the reservoir receptacle, and not align or engage themoveable member 70 in any other position of the cap 4 (orbase/reservoir/cap unit). In such embodiments, the size or shape (orboth) of the engagement portion 80 may be configured to provide arelatively precise detection of a proper connection of the cap 4 (orbase/reservoir/cap unit) with the infusion pump device 30.

In further embodiments, a plurality of engagement portions 80 areprovided at suitable locations on the cap 4 (or other component of thebase/reservoir/cap unit) to engage the second end 78 of the moveablemember 70 in a corresponding plurality of different insertion positionsof the cap 4 (or base/reservoir/cap unit) within the reservoirreceptacle 32. Thus, a user may insert the cap 4 (or base/reservoir/capunit) into the reservoir receptacle 32 in any of the plurality ofdifferent insertion positions to cause one of the engagement portions 80to engage the second end 78 of the moveable member 70. Alternatively orin addition, a plurality of engagement portions 80 may be provided atsuitable locations on the cap 4 (or base/reservoir/cap unit) toindividually engage the second end 78 of the moveable member 70 at acorresponding plurality of different positions of the cap 4 (orbase/reservoir/cap unit) as the cap 4 (or base/reservoir/cap unit) isbeing inserted or rotated within the reservoir receptacle 32. In suchembodiments, the electronics 60 are configured to detect multiplepositions of the cap 4 (or base/reservoir/cap unit) relative to thereservoir receptacle 32, for example, to detect an improper connectionof the cap 4 (or base/reservoir/cap unit) with the infusion pump device30 or to detect the movement of the cap 4 (or base/reservoir/cap unit)toward or away from a proper or full connection position relative to thereservoir receptacle 32.

In particular embodiments, the engagement portion 80 is provided on oneor more of the threads 19 (see FIG. 2) of the cap 4. In suchembodiments, the engagement portion 80 may be provided at a location ona thread 19 that is selected to align with the moveable member 70 whenthreads 19 are fully and properly threaded into corresponding threads orgrooves in the reservoir receptacle 32 of the infusion pump device 30(such as when the cap 4 or the base/reservoir/cap unit is fully andproperly received in the reservoir receptacle 32). In furtherembodiments, two engagement portions 80 are provided on two respectivethreads 19, where one thread 19 and engagement portion 80 is provided onan opposite side of the cap 4 or base/reservoir/cap unit (or 180 degreesaround the axis A) from the other thread 19 and engagement portion 80.Thus, with two engagement portions and threads on mutually oppositesides of the cap 4 (or base/reservoir/cap unit), or 180 degrees apart,the user may align threads on the cap 4 (or base/reservoir/cap unit)with threads on the reservoir receptacle 32 in either of two differentorientations 180 degrees relative to each other, to connect the cap 4(or base/reservoir/cap unit) to the infusion pump device 30.

In further embodiments, more than two threads 19 and engagement portions80 is provided at mutually spaced positions around the circumference ofthe cap 4 (or base/reservoir/cap unit), and a corresponding number ofthreads or grooves is provided in the reservoir receptacle 32 of theinfusion pump device 30, to accommodate more than two differentalignment orientations for threading the cap 4 (or base/reservoir/capunit) into the reservoir receptacle 32. In any of the embodimentsemploying threads 19, a plurality of engagement portions 80 may beprovided on any one or more of the threads 19. In such embodiments, oneor more engagement portions 80 may be arranged to engage and thendisengage the second end 78 of the moveable member 70, as the cap 4 (orbase/reservoir/cap unit) is threaded into the reservoir receptacle 32.The electronics 60 may be configured to detect and count the number ofengagements and disengagements, for determining whether or not the cap 4(or base/reservoir/cap unit) is fully and properly received in thereservoir receptacle 32. Alternatively or in addition, the electronics60 may be configured to detect a particular rotational position orlinear position (or both) of the cap 4 (or base/reservoir/cap unit)within the reservoir receptacle 32, based on the number of detectedengagements (or engagements and disengagements) of engagement portions80 with the moveable member 70.

For example, in embodiments in which two engagement portions 80 areprovided on a thread 19, the electronics 60 may be configured todetermine that a proper connection of the cap 4 (or base/reservoir/capunit) is made when the electronics 60 has detected two activations ofthe switch 76. Alternatively or in addition, the electronics may beconfigured to determine that the cap 4 (or base/reservoir/cap unit) hasbeen rotated by one half the proper amount (or other particular amount)or moved linearly by one half the proper amount (or other particularamount) within the reservoir receptacle, when only one activation of theswitch 76 has occurred. Other embodiments may employ any suitable numberof engagement portions 80 on one or more threads 19 (or on anothersuitable surface of the cap 4 or base/reservoir/cap unit).

As discussed herein, the movable member 70 is supported within a channel72 located in the housing 33 of the infusion pump device 30. Inparticular embodiments, the housing 33 includes a housing portion 33′that contains the channel 72 and further contains a volume in which theswitch 76 and circuit board 90 are located. In further embodiments, thehousing portion 33′ also includes at least a portion of or all of thereservoir receptacle 32. For example, with reference to the orientationin FIG. 17, the housing portion 33′ may include the upper portion (butnot the lower portion) of the reservoir receptacle 32, from the open endto a location below the channel 72. In such embodiments, the position ofthe channel 72 (and, thus, the position of the second end 78 of themoveable member 70) relative to the reservoir receptacle 32 can be madewith sufficiently high precision, for improving or controlling theprecision in detecting the position of a cap 4 (or base/reservoir/capunit) within the reservoir receptacle 32.

In one example embodiment, the housing portion 33′ forms part of thereservoir receptacle 32 or has a part that fits into or around thereservoir receptacle 32, and is molded to or otherwise adhered orconnected to a further portion of the housing 33 that forms thereservoir receptacle. In particular embodiments, the further portion ofthe housing 33 that forms the reservoir receptacle is molded over (oradhered to or otherwise connected to) a part of the housing portion 33′,for example, during manufacture or assembly of the infusion pump device30.

e. Optical Detection

Certain embodiments as described above include one or more magneticdetectable features and magnet detection sensors, while otherembodiments include one or more inductively, RF, or mechanicallydetectable features and one or more RF, inductive or mechanicaldetection sensors, and other embodiments include any combination of oneor more magnetic, inductive, RF or mechanical detectable features andsensors. In yet other embodiments, an optical detection is employed,where the one or more detectable features 42 include an opticallydetectable feature, while the one or more sensors 34 include an opticalsensor. In yet other embodiments, the one or more detectable features 42include a combination of two or more of a magnetically detectablefeature, an inductively detectable feature, an RF detectable feature, amechanically detectable feature and an optically detectable feature,while the one or more sensors 34 include a combination of two or more ofa magnetic sensor, an inductive sensor, an RF sensor, a mechanicalsensor and an optical sensor.

Accordingly, arrangements and configurations of magnetic, inductive, RFand mechanical sensor elements and detectable features (as the sensorelements and detectable features 34 and 42) as described above and shownin FIGS. 1-18 are incorporated herein by reference to apply toembodiments employing optical sensors and optically detectable features,as the sensor elements and detectable features 34 and 42. According tocertain embodiments, any suitable optical sensor and opticallydetectable feature may be employed as the one or more sensors anddetectable features 34 and 42 for optical detection of the presence orposition (or both) of the cap 4 (or base/reservoir/cap unit).

One example embodiment of an optical detection configuration isdescribed with reference to FIG. 19. The drawing in FIG. 19 shows apartial, top view of a portion 33″ of the infusion pump housing 33 ofthe infusion pump device 30. The housing portion 33″ may be similar tothe housing portion 33′ described above with respect to FIG. 17, but isconfigured with one or more optical sensors instead of one or moremechanical sensors described with reference to FIG. 17.

In the embodiment in FIG. 19, the housing portion 33″ includes at leasta part of the reservoir receptacle 32. In particular embodiments, thehousing portion 33″ includes the upper part of the reservoir receptacle32 and may be molded with or otherwise coupled to the rest of thereservoir receptacle, similar to the housing portion 33′ describedabove. In other embodiments, the housing portion 33″ includes the entirereservoir receptacle 32. In yet other embodiments, the housing portion33″ is a separate housing portion configured to be mounted to orsupported adjacent the reservoir receptacle 32.

As shown in FIG. 19, an optical emitter device 100 and an opticaldetector device 102 are supported and held by the housing portion 33″.The optical emitter device 100 is configured and arranged to emit anoptical beam or other optical output signal in a first direction(represented by arrow 104 in FIG. 19), toward the reservoir receptacle32. The optical detector device 102 is configured and arranged toreceive an optical beam or other optical signal along a second direction(represented by arrow 106 in FIG. 19), from the reservoir receptacle 32.In the embodiment of FIG. 19, the first direction and second directionare arranged at an angle relative to each other, but are aligned suchthat an optical signal transmitted in the direction of arrow 104 can bereflected from a predefined location on a cap 4 (or other portion of abase/reservoir/cap unit), along the direction of arrow 106. In otherembodiments, the optical emitter device 100 and the optical detectordevice 102 are supported in other suitable positions relative to eachother that allow an optical signal to be emitted from the opticalemitter device 100 and, then, received by the optical detector device102 after having been reflected from a surface of the cap 4 (or otherportion of the base/reservoir/cap unit).

The housing portion 33″ includes one or more passages through which anoptical signal transmitted in the direction of arrow 104 iscommunicated, and through which a reflected optical signal in thedirection of arrow 104 is communicated. In the embodiment of FIG. 19,the passages include a first channel 108 having longitudinal dimensionextending between the optical emitter device 100 and the reservoirreceptacle 32, and a second channel 110 having a longitudinal dimensionextending between the optical receiver device 102 and the reservoirreceptacle 32. In other embodiments, the passage(s) may have othersuitable forms such as, but not limited to one or more windows,openings, open or transparent (or partially transparent) sides of thereservoir receptacle or the like.

In particular embodiments, each of the channels includes a seal (forexample, seal 112 in channel 108 and seal 114 in channel 110) configuredto inhibit the passage of moisture, liquid or other fluid from theinterior of the reservoir receptacle 32 into the housing portion 33″. Inthe embodiment of FIG. 19, the seals 112 and 114 are in the form of anoptically transparent (or partially transparent) material that fills atleast a portion of the length of the channels 108 and 110 and seals withcontact against the interior surfaces of the channels. In furtherembodiments, additional sealing features are arranged on or around theoptically transparent (or partially transparent) material within thechannels 108 and 110, such as, but not limited to, one or more O-rings,sleeves or other structures made of a compressible or otherseal-enhancing material. The optically transparent (or partiallytransparent) material of the seals 112 and 114 may be any suitablematerial that sufficiently passes optical signals as described herein,including but not limited to plastic, glass or other ceramic material,or the like. As an alternative or in addition to the seals 112 and 114,a window covered by an optically transparent (or partially transparent)material may be arranged at the end of the channel(s) that interfacewith the reservoir receptacle 32. In particular embodiments, theoptically transparent (or partially transparent) material of the windowis composed of the material from which the housing portion 33″ is made,such that the window material is integral with the housing portion 33″.In other embodiments, the window material is formed separate from andthen attached to the housing portion 33″.

In the embodiment of FIG. 19, the seal 112 is part of a unitarystructure 116 that surrounds and encases (or partially surrounds andencases) the optical transmitter device 100. Similarly, the seal 114 ispart of a unitary structure 118 that surrounds and encases (or partiallysurrounds and encases) the optical transmitter device 102. In particularembodiments, the structures 116 and 118 form housings that seal orpartially seal the optical emitter device 100 and optical detectordevice 102 against moisture, liquid or other fluid. Thus, in certainembodiments, the optical transmitter device 100 and the optical receiverdevice 102 are encased (or partially encased) within structures 116 and118 during a manufacturing step, and can be stored or shipped for laterassembly within the housing portion 33″ as part of another manufacturingstep.

In particular embodiments, the housing portion 33″ is formed separatefrom other portions of the housing 33 (for example, as shown in FIG. 20)and then is molded or otherwise connected to another other portion ofthe housing 33. FIG. 20 shows a perspective view of a housing portion33″ that includes optical sensor features as described herein. In otherembodiments, the housing portion 33″ is molded or otherwise formed as aunitary structure with the rest of the housing 33. In the embodiment ofFIG. 20, the housing portion 33″ includes a hollow, generallycylindrical section 120 that forms a portion of the reservoir receptacle32 (for example, the upper portion of the reservoir receptacle 32relative to the orientation in FIG. 17).

In addition, the housing portion 33″ in FIG. 20 includes a supportsection 122 that holds and supports the optical emitter device 100 andthe optical detector device 102 in predefined, proper orientationsrelative to the reservoir receptacle 32. The support section 122 isfixed with respect to the reservoir receptacle. In particularembodiments, the support section 122 is molded or formed integral withreservoir receptacle 32. In other embodiments, the support section 122is formed separately and then fixedly secured to the reservoirreceptacle 32. By assembling the housing portion 33″ with the opticalemitter and detector devices 100 and 102 as a unitary structure, theorientation of those devices can be set at a factory or assembly plant(or by another authorized entity) for relatively precise aim and opticaldetection, prior to assembly of the housing portion 33″ with the rest ofthe housing 33 of the infusion pump device 30.

The cap 4 (or other portion of the base/reservoir/cap unit) includes oneor more (or a plurality of) features that affect an optically detectablecharacteristic of an optical signal emitted onto the feature(s). Morespecifically, when the cap 4 (or the base/reservoir/cap unit) isinserted into the reservoir receptacle 32, the outer surface of the cap4 (or other portion of the base/reservoir cap unit) is moved into aposition at which it is illuminated by the optical signal beam emittedfrom the optical emitter device 100. In particular embodiments, as thecap 4 (or base/reservoir/cap unit) is manually inserted into thereservoir receptacle 32, the cap 4 (or base/reservoir/cap unit) isrotated or moved linearly (or both) along axis A relative to infusionpump device 30, toward a fully installed position within the reservoirreceptacle 32. During that action, portions of the outer surface of thecap 4 (or other portion of the base/reservoir/cap unit) move past theoptical signal passage(s) in the housing portion 33″. Accordingly,different regions or areas of the outer surface of the cap 4 (orbase/reservoir/cap unit) become aligned with the optical signalpassage(s) and are illuminated (at least temporarily) by an opticalsignal from the optical emitter 100, as the cap 4 (or base/reservoir/capunit) is moved to its fully installed position within the reservoirreceptacle 32. In addition, once the cap 4 (or base/reservoir/cap unit)is in the fully and properly installed position within the reservoirreceptacle 32, a particular (predefined) region or area of the cap 4 (orother portion of the base/reservoir/cap unit) is aligned with theoptical signal passage(s) and is illuminated by an optical signal fromthe optical emitter 100.

Some or all of the surface of the cap 4 (or base/reservoir/cap unit)that becomes illuminated during installation of the cap 4 (orbase/reservoir/cap unit) is provided with one or more features thataffect or alter the optical signal in a detectable manner. In particularembodiments, a plurality of detectable features are provided on thesurface of the cap 4 (or base/reservoir/cap unit) at locations thatalign with the optical signal passage(s) in the housing portion 33″(and, thus, become illuminated by an optical signal from the opticalemitter 100) at different instantaneous positions of the cap 4 (orbase/reservoir/cap unit) as the cap 4 (or base/reservoir/cap unit) ismoved towards and into its fully and properly installed position withinthe reservoir receptacle 32. In such embodiments, the electronics 60 areconfigured to detect multiple different positions of the cap 4 (orbase/reservoir/cap unit) relative to the reservoir receptacle 32,including a fully and properly installed position, based on opticalsignals affected or altered by detectable features at the multipledifferent positions, as detected by the detector 102.

In particular embodiments, portions of the outer surface of the cap 4(or base/reservoir/cap unit) include an optically reflective featurethat reflects an optical signal emitted by the optical emitter 100. Forexample, the outer surface of the cap 4 (or base/reservoir/cap unit) maybe formed of or coated with an optically reflective material.Alternatively or in addition, an optically reflective material may beadhered to the cap 4 (or base/reservoir/cap unit). In such embodiments,one or more confined regions or areas on the cap 4 (orbase/reservoir/cap unit) is provided with a feature that is notoptically reflective or has a detectably different optical reflectivecharacteristic than other areas on the cap 4 (or base/reservoir/capunit). Accordingly, when the cap 4 (or base/reservoir/cap unit) isinitially inserted into the reservoir receptacle 32, an optical signalfrom the optical emitter 100 may illuminate the reflective material onthe cap 4 (or base/reservoir/cap unit) and be reflected to the opticaldetector 102. Electronics 60 may be configured to detect the presence ofthe cap 4 (or base/reservoir/cap unit) within the reservoir receptacle32, in response to the detection of the reflected signal by (and outputsignal of) the optical detector 102.

Then, as the cap 4 (or base/reservoir/cap unit) is rotated or linearlymoved (or both) toward its full and proper installation position withinthe reservoir receptacle 32, one or more of the regions or areasprovided with the feature that does not reflect (or alters a reflectioncharacteristic) is moved into alignment with the optical signalpassage(s) in the housing portion 33″. As a result, the optical signalfrom the optical emitter 100 is not reflected (or is reflected in adetectably different manner relative to other portions of the cap 4 orbase/reservoir/cap unit) and the optical detector 102 provides acorresponding output signal to the electronics 60. In such embodiments,the electronics 60 is configured to determine the position of the cap 4(or base/reservoir/cap unit), based on the output signal from theoptical detector 102.

By arranging the optically detectable features at predefined locationson the cap 4 (or base/reservoir/cap unit) that align with the opticalsignal passage(s) in the housing portion 33″ when the cap 4 (orbase/reservoir/cap unit) is at predefined, corresponding positionswithin the reservoir receptacle 32, the electronics 60 may be configuredto determine the position of the cap 4 (or base/reservoir/cap unit)within the reservoir receptacle 32 by counting the detected opticalfeatures detected by (or otherwise evaluating the output signal receivedfrom) the optical detector 102 as the cap 4 (or base/reservoir/cap unit)is moved into the reservoir receptacle 32. Furthermore, by arranging atleast one optically detectable feature at a predefined location on thecap 4 (or base/reservoir/cap unit) that aligns with the optical signalpassage(s) in the housing portion 33″ when the cap 4 (orbase/reservoir/cap unit) is at the fully and properly installed positionwithin the reservoir receptacle 32, the electronics 60 may be configuredto determine that the cap 4 (or base/reservoir/cap unit) is fully andproperly installed within the reservoir receptacle 32, based on anoutput signal from the optical detector 102 corresponding to thedetection of that feature.

In the above embodiments in which the outer surface of the cap 4 (orbase/reservoir/cap unit) has an optically reflective outer surface andthe detectable feature(s) include one or more features that are notoptically reflective or have a different reflective characteristic(detectable parameter), the one or more features may include, but arenot limited to, a material, coating, surface contour or pattern (ribs,grooves, undulations, roughness, abrasions, apertures, or the like) orattached article that inhibits or changes optical reflectivecharacteristics. In particular embodiments, the one or more opticallydetectable features include one or more apertures or detents in thereflective outer surface of the cap 4 (or base/reservoir/cap unit). Inyet further embodiments, the one or more optically detectable featuresinclude the existence of one or more optically detectable feature on thecap; the location or pattern of locations of one or more opticallydetectable feature on the cap; the type of optically detectable featureon the cap; the type or content of data stored by the opticallydetectable feature; or the polarity, direction or orientation of thesignal emitted by the optically detectable feature. In yet furtherembodiments, the optically detectable feature includes amachine-readable pattern of optically detectable regions, such as, butnot limited to a bar code or 2D data matrix or liner code. In suchembodiments, the pattern of optically detectable regions representsencoded information that can be read by electronics 60. In particularembodiments, the one or more optically detectable features include oneor more adhesive-backed tags that are adhered to the cap 4 (orbase/reservoir/cap unit) at one or more predefined locations and thathave an outer surface has an optically detectable feature as describedherein or otherwise inhibits or detectably alters reflection of anoptical signal from the optical emitter 100.

In other embodiments, the outer surface of the cap 4 (orbase/reservoir/cap unit) is configured to inhibit optical reflection,while the one or more optically detectable features are configured to bedetectably reflective. In such embodiments, the electronics 60 isconfigured to detect one or more relative positions of the cap 4 (orbase/reservoir/cap unit) within the reservoir receptacle 32 byevaluating signals from the optical detector 102 representing detectionof the reflective optically feature(s) on the cap 4 (orbase/reservoir/cap unit).

In further embodiments, one or more optically detectable features on thecap 4 (or base/reservoir/cap unit) are configured to alter the opticalsignal in an optically detectable manner by altering one or more of thewavelength, direction, phase or other detectable parameter of theoptical signal. In yet further embodiments, a plurality of differentoptically detectable features are provided on the cap 4 (orbase/reservoir/cap unit) at respectively different predefined locationsrelative to each other, such that a different respective detectablefeature is aligned with the optical signal passage(s) in the housingportion 33″ at different respective positions of the cap 4 (orbase/reservoir/cap unit) within the reservoir receptacle 32. In suchembodiments, each different optically detectable feature can beconfigured to provide to the optical detector 102 a different detectablereflective signal (relative to the other optically detectable featureson the cap 4 or base/reservoir/cap unit), when aligned with the opticalsignal passage in the housing portion 33″. Accordingly, the opticaldetector 102 is provided a different detectable reflected signal and,thus, provides a different output signal at different respectivepositions of the cap 4 (or base/reservoir/cap unit). In suchembodiments, the electronics 60 is configured to determine the positionof the cap 4 (or base/reservoir/cap unit) relative to the reservoirreceptacle 32, based on the output signal of the optical detector 102.

The optical emitter device 100 may be any suitable device that emits anoptically detectable signal. In particular embodiments, the opticalemitter device 100 includes a light emitting diode (LED) device and LEDdriver circuit that is configured to produce an optical output signalhaving a predefined wavelength or peak wavelength, radiant intensity,angle of intensity, or ranges thereof. In particular embodiments, theoptical emitter device 100 is an infrared (IR) device configured toprovide an IR output signal. In other embodiments, other suitableoptical emitter devices may be employed including, but not limited to,devices that operate in other wavelengths outside of IR.

The optical detector device 102 may be any suitable device that detectsan optical signal output by the optical emitter 100 and reflected fromthe cap 4 (or base/reservoir/cap unit). In embodiments in which theoptical emitter 100 includes an IR LED device, the optical detectordevice 102 includes an IR phototransistor or other device configured todetect IR radiation. In other embodiments, the optical detector device102 may include, but is not limited to, one or more of aphototransistor, photoresistor, photodiode, photovoltaic cell,photomultiplier, photo Schmitt Trigger, charge-coupled device (CCD),active-pixel sensor (APS) or other suitable device that reacts in adetectable matter to an optical signal.

The embodiment of FIGS. 19 and 20 includes one optical sensor composedof an optical emitter-detector pair 100, 102. In other embodiments, twoor more (a plurality of) optical sensors (composed of two or moreoptical emitter-detector pairs 100, 102) are arranged at predefinedlocations around or along the reservoir receptacle 32. In particularembodiments, one or more optical sensors (optical emitter-detectorpairs) are arranged to detect the position of the cap 4 relative to theinfusion pump device 30 (e.g., for detecting a proper connection of thecap 4 or the base/reservoir/cap unit with the infusion pump device 30).

In other embodiments, one or more optical sensors (opticalemitter-detector pairs) are employed to detect one or more othercharacteristics associated with the cap 4 or the base/reservoir/cap unitor components thereof, in addition to or as an alternative to detectingproper connection with the infusion pump device 30. In variousembodiments, such other characteristics include but are not limited tocharacteristics of the reservoir 1 (or its contents), infusion set 50,connection interface 40, or any combination thereof, as described abovewith respect to magnetic detection, RF detection or mechanicaldetection.

In those embodiments, a particular characteristic may be associated withone or more detectable parameters of the optically detectable elements,such as, but not limited to: the existence of one or more opticallydetectable elements on the cap 4, the location or pattern of locationsof one or more optically detectable elements on the cap 4(circumferential or linearly location relative to the dimension of theaxis A), the optically detectable pattern, shape, wavelength or peakwavelength, radiant intensity, angle of intensity or other detectableparameter of the optically detectable elements, or any combinationthereof. In particular embodiments, each different predefinedcharacteristic of the reservoir 1, infusion set 50 or connectioninterface 40, is associated (for example, on a one-to-one basis) with arespectively different predefined detectable parameter of the opticallydetectable elements. In those embodiments, the processing electronics 62are configured to determine a characteristic of the reservoir 1,infusion set 50 or connection interface 40 from the signals receivedfrom the one or more optical sensors (optical emitter-detector pairs),for example, using a process as described with respect to process 150 inFIG. 6.

For example, the processing electronics 62 may be configured to compareinformation received from one or more optical sensors (opticalemitter-detector pairs) with information stored in a table or in anothersuitable data arrangement. The table or other data arrangement is storedin the electronic memory 66. The table or other data arrangementassociates a plurality of different predefined optically detectableelements, or locations or patterns of locations of one or more opticallydetectable elements, the optically detectable pattern, shape or otherparameter of the optically detectable elements, or any combinationthereof with a corresponding plurality of predefined characteristics, asdescribed above with respect to the magnetic, RF and mechanicaldetection embodiments and incorporated herein by reference.

In particular embodiments, based on one or more of the parameters (oroptical signature) detected from the signals received from the one ormore optical sensors (optical emitter-detector pairs), the processingelectronics 62 is further configured to determine correspondingcharacteristics and, based on those characteristics, do one or more of:determine operational settings for the infusion pump device 30, providesignals to the drive device or other components of the infusion pumpdevice 30, provide one or more alarm signals, and record datarepresenting detected states or conditions of one or more of the cap 4,base/reservoir/cap unit, and infusion pump device 30, as described abovewith regard to magnetic detection, RF detection and mechanicalembodiments.

In further embodiments, one or more wireless or wired communicationdevices is provided on the infusion pump device 30 (or other deliverydevice) and is configured and controlled to transmit volume informationrelating to the volume of infusion fluid remaining in or dispensed fromthe reservoir 1 (or other information corresponding to detectedparameters of the one or more optically detectable elements orassociated characteristics) for display on another electronic deviceseparate from or located remote from the infusion pump device 30. Inparticular embodiments, the wireless communication device(s) areconfigured to connect for communication on a communication network (suchas, but not limited to the Internet), with one or more pre-definednetwork connected devices. Such one or more pre-defined networkconnected devices may be located at remote geographic locations relativeto the infusion pump device 30 (or other delivery device). In particularembodiments, such network connected devices include a server configuredto receive information from the infusion pump device 30 (or otherdelivery device) or from another network connected device (such as acradle, user computer, or the like) that communicates with the infusionpump device 30 (or other delivery device). Such information may include,but is not limited to information corresponding to one or more detectedparameters or one or more associated characteristics, or otherinformation regarding the reservoir 1, cap 4, base/reservoir/cap unit orinfusion set as described above.

In such embodiments, the network connected server may be associated withan entity that records information, supplies associated products such asrefills or replacement parts, provides medical treatment or medicalinsurance to the user or the like. In one example, the network connectedserver is associated with the Carelink™ system of Medtronic Inc. Inother embodiments, the network connected server is one or more otherservers and associated entities. Accordingly, such information may beemployed by the server (or associated entity) to determine whether ornot (or when) to send refills, new or replacement reservoirs, caps,infusion set needle housings, infusion set tubing, or other componentsof the cap 4, base/reservoir/cap unit, or infusion set. In furtherembodiments, such information may be provided to the user's doctor orother medical treatment entity associated with the user (for tracking,diagnosing, adjusting treatment plans or other suitable uses). Thus, insuch embodiments, refills or replacement components may be sent tousers, automatically (without requiring the user to place an order), andusage information can be provided to the user's healthcare provider,insurance provider or other suitable entities, automatically.

In further embodiments, the network connected server is configured toprovide (and the infusion pump device 30 or other delivery device isconfigured to receive) information through the above-noted networkcommunication connection or other network connection. Such informationmay include, but is not limited to, instructions or recommendations forreplacing or refilling a reservoir 1, cap 4, base/reservoir/cap unit orinfusion set, messages or notices from healthcare providers, insurancecarriers or manufacturers, recall notices or the like. In particularembodiments, electronics (such as electronics 60) in the infusion pumpdevice 30 (or other delivery device) is configured to perform one ormore predefined actions (as discussed above) in response to receipt of apredefined instruction, notice or message.

f. Electrical Contact Detection

Certain embodiments as described above include one or more magneticdetectable features and magnet detection sensors, while otherembodiments include one or more inductively, RF, mechanically oroptically detectable features and inductive, RF, mechanical or opticaldetection sensors. Other embodiments include any combination of one ormore magnetic, inductive, RF, mechanical or optical detectable featuresand sensors. In yet other embodiments, an electrical contact detectionis employed, where the one or more detectable features 42 include afirst electrical contact feature, while the one or more sensors 34include an electrical contact sensor having a further electrical contactfeature arranged to selectively make electrical contact with the firstelectrical contact feature. In yet other embodiments, the one or moredetectable features 42 include a combination of two or more of amagnetically detectable feature, an inductively detectable feature, anRF detectable feature, a mechanically detectable feature, an opticallydetectable feature, or an electrical contact feature while the one ormore sensors 34 include a combination of two or more of a magneticsensor, an inductive sensor, an RF sensor, a mechanical sensor, anoptical sensor and an electrical contact sensor.

Accordingly, arrangements and configurations of magnetic, inductive, RF,mechanical and optical sensor elements and detectable features (as thesensor elements and detectable features 34 and 42) as described aboveand shown in FIGS. 1-20 are incorporated herein by reference to apply toembodiments employing electrical contact sensors and electrical contactfeatures, as the sensor elements and detectable features 34 and 42.According to certain embodiments, any suitable electrical contact sensorand electrical contact feature may be employed as the one or moresensors and detectable features 34 and 42 for electrical contactdetection of the presence or position (or both) of the cap 4 (orbase/reservoir/cap unit).

Example embodiments of electrical contact detection configurations aredescribed with reference to FIGS. 21-27. The drawing in FIG. 21 shows apartial, top view of a portion of the infusion pump housing 33 of theinfusion pump device 30, including the open end portion of the reservoirreceptacle 32. The cap 4 is provided with a first electrical contactfeature 130 attached to the body 5 of the cap 4. The first electricalcontact feature 130 is provided at a location on the cap body 5 toengage and make electrical contact with a second electrical contactfeature 132 on the infusion pump device 32, when the cap 4 (orbase/reservoir/cap unit) is installed in the reservoir receptacle of theinfusion pump device 32.

Each of the electrical contact features 130 and 132 may include one ormore of any suitable electrically conductive material, including, butnot limited to, an electrically conductive metal member, plating,coating, ink, or other material suitable for making an electricalcontact as described herein. The electrical contact feature 130 may beattached to, embedded in, molded in, applied onto or otherwise affixedto a wall portion of the cap body 5. Similarly, the electrical contactfeature 132 may be attached to, embedded in, molded in, applied onto orotherwise affixed to a wall portion of the housing 33 within thereservoir receptacle 32.

In particular embodiments, one or both of the electrical contactfeatures 130 and 132 includes a biased portion that is biased in aradial direction relative to the axis A, for example, where the firstelectrical contact feature 130 is biased radially outward (away from theaxis A), or the second electrical contact feature 132 is biased radiallyinward relative to the axis A (or both electrical contact features arebiased). In particular embodiments, at least one of the electricalcontact features 130 and 132 has smooth, strip or pad configuration. Inthe embodiment in FIG. 21, the electrical contact feature 130 includestwo biased contact portions 130 a and 130 b, while the electricalcontact feature 132 includes two contact pads 132 a and 132 b. In otherembodiments, as shown in FIG. 22, the electrical contact feature 130includes an electrically conductive strip or elongated pad, while theelectrical contact feature 132 includes two biased, electricallyconductive members 132 c and 132 d. In other embodiments, the electricalcontact features 130 and 132 have other suitable configurations.

Example electrical contact feature configurations 130 (detached from thecap body 5) are shown in FIGS. 23A-23E. In the embodiment of FIG. 23A,the electrical contact feature 130 includes first and second biasedextension portions 130 a and 130 b, similar to the electrical contactfeature 130 in FIG. 21. The electrical contact feature 130 in FIG. 23Amay be made of a sheet or strip of electrically conductive metalmaterial having extension portions 130 a and 130 b that are bent orfolded partially to extend outward from the rest of the sheet or strip.The material has sufficient flexibility to allow the extension portions130 a and 130 b to bend or fold further inward toward the rest of thesheet or strip when a pressing force is applied to the extensionportions 130 a and 130 b. In addition, the material has a natural springforce sufficient to bias the extension portions 130 a and 130 b toward anon-pressed state (as shown in FIG. 23A), when a pressing force isapplied.

In the embodiments of FIGS. 23B and 23C, the electrical contact feature130 includes a plurality (two, in the illustrated embodiments) ofseparate biased members (130 c and 130 d in FIG. 23B and 130 e and 130 fin FIG. 23C). In the embodiment of FIG. 23B, each of the biased members130 c and 130 d may be formed of a strip or sheet of electricallyconductive metal that is bent or folded similar to the extensionportions 130 a and 130 b of FIG. 23A. However, the biased members 130 cand 130 d are separate members that are electrically coupled together byan electrical conductor 134, such as, but not limited to a conductivewire or conductive trace on the cap body 5. Each biased member 130 c and130 d may be supported on a wall portion of the cap body 5, for example,as shown in FIG. 23E.

In the embodiment of FIG. 23C, each biased member 130 e and 130 fincludes an electrically conductive body 136 engaged or connected with abias spring 138, and is biased outward (e.g., outward from the cap body5) by the bias spring 138. Each biased member 130 e and 130 f may besupported on a wall portion of the cap body 5, for example, within arecess or groove in the cap body 5, as shown in FIG. 23E. The biasedmembers 130 e and 130 f are separate members that are electricallyconnected together by an electrical conductor 139, such as, but notlimited to a conductive wire or conductive trace on the cap body 5. Inparticular embodiments, the bias springs 138 are made of an electricallyconductive material and are electrically coupled to the electricalconductor 139 and the respective electrically conductive bodies 136, toelectrically couple the bodies 136 together.

In the embodiment of FIG. 21, when the cap 4 (or base/reservoir/capunit) is moved in the direction of axis A, into the reservoir receptacle32, the biased members 130 a and 130 b engage and slide along the innersurface of the reservoir receptacle 32. When the cap 4 (orbase/reservoir/cap unit) reaches a fully installed position within thereservoir receptacle, the biased members 130 a and 130 b align with andelectrically contact the pads 132 a and 132 b, respectively. Because thebiased members 130 a and 130 b are electrically connected together, thepads 132 a and 132 b become electrically connected together (through theelectrical contact feature 130), when the biased members 130 a and 130 bcontact the pads 132 a and 132 b.

Prior to being contacted by the biased members 130 a and 130 b, the pads132 a and 132 b are electrically separated from each other, butconnected to a sensor circuit that is configured to detect electricalconnection (or shorting) of the pads 132 a and 132 b. Accordingly, thesensor circuit 34 is configured to detect a condition of the pads 132 aand 132 b being electrically connected together (or shorted) when thepads 132 a and 132 b are contacted by the biased members 130 a and 130b, respectively.

In the embodiment of FIG. 22, biased members 132 c and 132 d areprovided on or in the interior wall of the reservoir receptacle 32, asdescribed above. FIGS. 26 and 27 may also represent examples of biasedmembers 132 on a wall portion of the housing 33 of the infusion pumpdevice. While the embodiments of FIGS. 21 and 22 show an electricalcontact feature 130 on the body 5 of the cap 4, in other embodiments,the electrical contact feature 130 is provided on the body of thereservoir 1 in a similar manner as described with respect to the capbody 5. In such embodiments, the electrical contact feature 132 isarranged further into the reservoir receptacle (relative to thearrangement in FIG. 21) to align with the electrical contact feature onthe body of the reservoir 1, when the base/reservoir/cap unit isproperly installed in the reservoir receptacle.

In particular embodiments, the electrical contact feature 132 isprovided in a wall portion of the housing 33 of the infusion pump device30. In other embodiments, the electrical contact feature 132 is providedin an upper ring member 137 that is connected to the housing 33 of theinfusion pump device, at the upper end (the open end) of the reservoirreceptacle 32. The upper ring member 137 may be made of any suitablyrigid material, such as, but not limited to plastic, metal, ceramic,wood, composite material, or any combination thereof, and may beconnected to the housing 33 in any suitable manner, including, but notlimited to threads, screws, bolts, clamps, adhesive materials, welds,slot and groove connectors or the like. In such embodiments, the upperring member 137 may include some or all of the electronics 60.Alternatively, the upper ring member 137 may include one or moreelectrical contacts that electrically connect with correspondingelectrical contacts on the housing 33, to electrically couple theelectrical contact feature 132 with electronics 60 located in theinfusion pump device 30.

In particular embodiments, electronics 60 (coupled with the sensorcircuit is 34) is configured to detect the presence of the cap 4 (orbase/reservoir/cap unit) in a properly installed position within thereservoir receptacle, in response to a detection of the pads 132 a and132 b being electrically connected together (or shorted) by theelectrical contact feature 130 on the cap 4. In other embodiments, theelectronics 60 is configured to detect other parameters associated withthe electrical contact feature 130 and associate the detected parameterswith one or more characteristics of the cap 4 (or associated reservoir 1or base/reservoir/cap unit, or infusion set connected thereto).

In particular embodiments of FIGS. 21-23E, one or more portions of theouter surface of the cap 4 (or base/reservoir/cap unit) include anelectrical contact feature 130. In such embodiments, one or more otherregions or areas on the cap 4 (or base/reservoir/cap unit) is notelectrically conductive or conducts in a detectably different mannerthan the electrical contact feature 130. Accordingly, when the cap 4 (orbase/reservoir/cap unit) is in a fully installed position within thereservoir receptacle 32 such that the electrical contact features 130and 132 engage each other, the first electrical contact feature 130completes or closes an electrical circuit between conductive elements(pads 132 a and 132 b, or biased members 132 c and 132 d) of the secondelectrical contact feature 132. Electronics 60 may be configured todetect the presence of the cap 4 (or base/reservoir/cap unit) within thereservoir receptacle 32, in response to the detection of the closedelectrical circuit between conductive elements (pads 132 a and 132 b, orbiased members 132 c and 132 d) of the second electrical contact feature132.

If the cap 4 (or base/reservoir/cap unit) is rotated or linearly moved(or both) away from a fully installed position within the reservoirreceptacle 32, the electrical contact feature 130 on the cap 4 (orbase/reservoir/cap unit) is moved out of engagement with the electricalcontact feature 132 on the reservoir receptacle 32. As a result, theelectrical circuit is broken or disconnected between the conductiveelements (pads 132 a and 132 b, or biased members 132 c and 132 d) ofthe second electrical contact feature 132. Electronics 60 may beconfigured to detect the movement of the cap 4 (or base/reservoir/capunit) from a fully installed position within the reservoir receptacle32, in response to the detection of the electrical circuit being brokenbetween conductive elements (pads 132 a and 132 b, or biased members 132c and 132 d) of the second electrical contact feature 132.

In further embodiments, a plurality of electrical contact features 130are arranged at a corresponding plurality of different predefinedlocations on the cap 4 (or base/reservoir/cap unit), such that one ormore electrical contact features 130 align with one or more electricalcontact features 132 in the reservoir receptacle 32, when the cap 4 (orbase/reservoir/cap unit) is at predefined, corresponding positionswithin the reservoir receptacle 32. In such embodiments, the electronics60 may be configured to determine the position of the cap 4 (orbase/reservoir/cap unit) within the reservoir receptacle 32 by countingelectrical circuit connections (shorts) or disconnections (breaks)detected as the cap 4 (or base/reservoir/cap unit) is moved into thereservoir receptacle 32.

In further embodiments, one or more electrical contact features on thecap 4 (or base/reservoir/cap unit) are configured to have apredetermined electrically detectable characteristic or parameter, suchas, but not limited to, a particular electrical resistance or impedancecharacteristic or parameter. In such embodiments, the electronics 60 isconfigured to detect the one or more characteristics or parameters ofthe electrical contact feature 130 and associate the detectedcharacteristic(s) or parameter(s) with one or more characteristics ofthe cap 4 (or base/reservoir/cap unit), or with the reservoir 1 (or itscontents), infusion set 50, connection interface 40, or any combinationthereof, as described above with respect to magnetic detection, RFdetection, mechanical detection or optical detection.

In yet further embodiments, a plurality of different electrical contactfeatures 130, each having a different electrically detectablecharacteristic relative to the others, are provided on the cap 4 (orbase/reservoir/cap unit) at respectively different predefined locationsrelative to each other. In such embodiments, a different respectiveelectrical contact feature 130 on the cap (or base/reservoir/cap unit)is aligned with the electrical contact feature 132 in the reservoirreceptacle 32 at different respective positions of the cap 4 (orbase/reservoir/cap unit) within the reservoir receptacle 32.Accordingly, the electronics 60 may be configured to determine theposition of the cap 4 (or base/reservoir/cap unit) relative to thereservoir receptacle 32, based on the particular electricalconnection(s) (short(s)) or disconnection(s) (break(s)) detected as thecap 4 (or base/reservoir/cap unit) is moved relative to the reservoirreceptacle 32

In particular embodiments, each different predefined characteristic ofthe cap 1, base/reservoir/cap unit, reservoir 1, infusion set 50 orconnection interface 40, is associated (for example, on a one-to-onebasis or other predefined association) with a respectively differentpredefined detectable location, pattern of locations, or otherdetectable characteristic or parameter of the electrical contactfeature(s) 130. In those embodiments, the processing electronics 62 areconfigured to determine a characteristic of the cap 4,base/reservoir/cap unit, reservoir 1, infusion set 50 or connectioninterface 40 from the signals received from the sensor 34 connected withthe electrical contact feature(s) 132.

For example, the processing electronics 62 may be configured to compareinformation received from one or more sensors 34 with information storedin a table or in another suitable data arrangement. The table or otherdata arrangement is stored in the electronic memory 66. The table orother data arrangement associates a plurality of different predefinedelectrically detectable characteristics or parameters, or locations orpatterns of locations of one or more electrical contact feature(s) 130,or any combination thereof with a corresponding plurality of predefinedcharacteristics of the cap 4, base/reservoir/cap unit, reservoir 1,infusion set 50 or connection interface 40.

In particular embodiments, based on one or more of the characteristicsor parameters detected from the electrical contact feature 130, theprocessing electronics 62 is further configured to determinecorresponding characteristics (for example, using a process 150 asdescribed with respect to FIG. 6) and, based on those characteristics,do one or more of: determine operational settings for the infusion pumpdevice 30, provide signals to the drive device or other components ofthe infusion pump device 30, provide one or more alarm signals, andrecord data representing detected states or conditions of one or more ofthe cap 4, base/reservoir/cap unit, and infusion pump device 30, asdescribed above with regard to magnetic detection, inductive detection,RF detection, mechanical embodiments and optical detection.

In further embodiments, one or more wireless or wired communicationdevices is provided on the infusion pump device 30 (or other deliverydevice) and is configured and controlled to transmit volume informationrelating to the volume of infusion fluid remaining in or dispensed fromthe reservoir 1 (or other information corresponding to detectedparameters of the one or more electrical contact detectable elements orassociated characteristics) for display on another electronic deviceseparate from or located remote from the infusion pump device 30. Inparticular embodiments, the wireless communication device(s) areconfigured to connect for communication on a communication network (suchas, but not limited to the Internet), with one or more pre-definednetwork connected devices. Such one or more pre-defined networkconnected devices may be located at remote geographic locations relativeto the infusion pump device 30 (or other delivery device). In particularembodiments, such network connected devices include a server configuredto receive information from the infusion pump device 30 (or otherdelivery device) or from another network connected device (such as acradle, user computer, or the like) that communicates with the infusionpump device 30 (or other delivery device). Such information may include,but is not limited to information corresponding to one or more detectedparameters or one or more associated characteristics, or otherinformation regarding the reservoir 1, cap 4, base/reservoir/cap unit orinfusion set as described above.

In such embodiments, the network connected server may be associated withan entity that records information, supplies associated products such asrefills or replacement parts, provides medical treatment or medicalinsurance to the user or the like. In one example, the network connectedserver is associated with the Carelink™ system of Medtronic Inc. Inother embodiments, the network connected server is one or more otherservers and associated entities. Accordingly, such information may beemployed by the server (or associated entity) to determine whether ornot (or when) to send refills, new or replacement reservoirs, caps,infusion set needle housings, infusion set tubing, or other componentsof the cap 4, base/reservoir/cap unit, or infusion set. In furtherembodiments, such information may be provided to the user's doctor orother medical treatment entity associated with the user (for tracking,diagnosing, adjusting treatment plans or other suitable uses). Thus, insuch embodiments, refills or replacement components may be sent tousers, automatically (without requiring the user to place an order), andusage information can be provided to the user's healthcare provider,insurance provider or other suitable entities, automatically.

In further embodiments, the network connected server is configured toprovide (and the infusion pump device 30 or other delivery device isconfigured to receive) information through the above-noted networkcommunication connection or other network connection. Such informationmay include, but is not limited to, instructions or recommendations forreplacing or refilling a reservoir 1, cap 4, base/reservoir/cap unit orinfusion set, messages or notices from healthcare providers, insurancecarriers or manufacturers, recall notices or the like. In particularembodiments, electronics (such as electronics 60) in the infusion pumpdevice 30 (or other delivery device) is configured to perform one ormore predefined actions (as discussed above) in response to receipt of apredefined instruction, notice or message.

Another example embodiment of electrical contact detection configurationis shown in FIGS. 24 and 25. The drawing in FIG. 24 shows a cap 4 thatis provided with a pair of first electrical contact features 161 and 162and an infusion pump device 30 that is provided with a second pair ofelectrical contact features 163 and 164. The drawing in FIG. 25 shows aportion of the infusion pump device 30, with the cap 4 of FIG. 24 (orbase/reservoir/cap unit including the cap 4 of FIG. 24) in an installedstate.

The first electrical contact features 161 and 162 are arranged to engageand make electrical contact with a pair of second electrical contactfeature 163 and 164 on the infusion pump device 30, when the cap 4 (orbase/reservoir/cap unit) is installed in the reservoir receptacle of theinfusion pump device 32. However, the second electrical contact features163 and 164 are arranged at a location on the housing 33 of the infusionpump device 30, external to the reservoir receptacle 32. Accordingly,the first and second contact features 161-164 engage with each other,outside of the reservoir receptacle 32, when the cap 4 (orbase/reservoir/cap unit) is installed in the reservoir receptacle of theinfusion pump device 32.

In the embodiment in FIG. 24, the second electrical contact features 163and 164 are arranged on a surface 33 a of the housing 33, where thesurface 33 a faces in the same direction (or substantially in the samedirection) as axis A and the open end of the reservoir receptacle 32 ofthe infusion pump device 30. In other embodiments, the second electricalcontact features 163 and 164 may be located at other suitable surfacesof the housing 33 or other suitable locations on the infusion pumpdevice 30.

In the embodiment in FIG. 24, the first electrical contact features 161and 162 are supported on an extension portion 166 of the cap 4. Theextension portion extends outward from the axis A, over the surface 33 aof the housing 33, when the cap 4 (or base/reservoir/cap unit) isinstalled in the reservoir receptacle of the infusion pump device 32. Inparticular embodiments, the extension portion 166 is an integral portionof the housing 5 of the cap. For example, the extension portion 166 maybe formed with (and with the same material as) the rest of the housing5, for example, in a molding process or the like. In other embodiments,the extension portion 166 is formed separate from the housing 5 of thecap 4 and, then, is attached to the housing 5 by any suitable connectionmechanism including, but not limited to adhesive, welding, soldering,connectors or the like.

In particular embodiments, the first electrical contact features 161 and162 are arranged to engage and make electrical contact with a pair ofsecond electrical contact feature 163 and 164, when the cap 4 (orbase/reservoir/cap unit) is in a fully and properly installed positionwithin the reservoir receptacle 32 of the infusion pump device 30, butdo not engage and make electrical contact with a pair of secondelectrical contact feature 163 and 164, when the cap 4 (orbase/reservoir/cap unit) is not in a fully and properly installedposition within the reservoir receptacle 32. More specifically, when thecap 4 (or base/reservoir/cap unit) is fully and properly installed, theone first electrical contact feature 161 is arranged to engage onesecond electrical contact feature 163, while the other first electricalcontact feature 162 is arranged to engage the other second electricalcontact feature 164. In this manner, an electrical contact between thefirst and second pairs of electrical contact features is made, only whenthe cap 4 (or base/reservoir/cap unit) is in a fully and properlyinstalled position within the reservoir receptacle 32.

In particular embodiments, the first and second electrical contactfeatures 161-164 may be configured and operate similar to the first andsecond contact features 130 and 132 described above. In furtherembodiments, the first electrical contact features are part of (or areelectrically connected with) electrical terminals of an electroniccircuit such as, but not limited to an integrated circuit (IC) chip 168,carried by the cap 4. In such embodiments, the IC chip 168 includes anEPROM, ROM, PROM or other suitable electronic storage device that storeselectronic data and/or programming. In such embodiments, electronicswithin the infusion pump device 30 (e.g., electrical circuit 170described below and/or electrical circuit 60 described above withrespect to FIG. 5) may be configured to read data from the electronicstorage device, when an electrical contact between the first and secondpairs of electrical contact features is made. In further embodiments,such electronics within the infusion pump device 30 may be configured towrite data to the electronic storage device (e.g., the IC chip 168).

Data stored on or written to the electronic storage device (e.g., the ICchip 168) may include any suitable data, such as, but not limited todata associated with one or more characteristics of the cap 4 (or othercomponent of the base/reservoir/cap unit, or the infusion set, infusionpump device 30 or user), including, but not limited to one or more of: atype or identity of a manufacturer of the reservoir, cap or infusionpump device; a size of the reservoir, cap or infusion pump device; atype or concentration of infusion media in the reservoir; a volumeamount of infusion media in the reservoir; a date corresponding to amanufacturing date, expiration date or fill date related to infusionmedia in the reservoir; a date corresponding to a manufacturing date orexpiration date of the reservoir, cap or infusion pump device; alocation corresponding to a place where the reservoir or infusion mediain the reservoir was made, filled, or otherwise processed; a locationcorresponding to a place where the cap or infusion pump device was made,assembled or otherwise processed; a location corresponding to a placewhere the reservoir, infusion media in the reservoir, cap or infusionpump device is authorized to be used; a lot number or code associatedwith a batch in which the reservoir, cap, infusion pump device orinfusion media was made, cleaned, filled or otherwise processed; aserial number; a unique ID; user identification information forauthorized users.

In the embodiment in FIGS. 24 and 25, the second electrical contactfeatures 163 and 164 on the infusion pump device 30 are electricallyconnected with (or are part of) an electrical circuit 170 containedwithin the housing 33 of the infusion pump device 30. In particularembodiments the electrical circuit 170 may be part of or include anelectrical circuit 60 as described above with respect to FIG. 5, wherethe sensor element 34 in FIG. 5 represents the second electrical contactfeatures 163 and 164, or is connected with the second electrical contactfeatures 163 and 164, to detect electrical connection of the firstelectrical contact features 161 and 162 making electrical contact withthe second electrical contact features 163 and 164. In such embodiments,detection of electrical contact of the first and second electricalcontact features 161-164 may be similar to the detection of electricalcontact between electrical contact features in the embodiments of FIGS.21-23E. In other embodiments, detection of electrical contact of thefirst and second electrical contact features 161-164 may be carried outby other suitable detection electronics.

In particular embodiments, the electrical circuit 170 includes acontroller circuit, such as, but not limited to a microcontroller (μc)172 and a resistor circuit and/or other circuit components. Also inparticular embodiments, the electrical circuit 170 may be provided on aprinted circuit board assembly (PCBA) 174 located within the housing 33of the infusion pump device 30.

The first and second electrical contact features 161-164 may be formedas pads of metal or other electrically conductive material. In otherembodiments, the first electrical contact features 161 and 162, or thesecond electrical contact features 163 and 164 (or each of the first andsecond electrical contact features 161-164) may include an electricallyconductive member that is spring biased or otherwise supported formovement against a bias force, such as, but not limited to a pogoconnector, spring biased connector or the like. In such embodiments, oneor both of the pair of first electrical contact features 161-162 and thepair of second electrical contact features 163-164 are arranged to pressagainst the other pair of the first or second electrical contactfeatures and move against the bias force (e.g., spring force), such thatthe first and second electrical contact features are positively engagedwith each other, by the bias force, when the cap 4 (orbase/reservoir/cap unit) is in a fully and properly installed positionwithin the reservoir receptacle 32. In other embodiments, other suitableelectrical connectors may be employed with or for the first and secondelectrical contact features 161-164, including, but not limited to snapconnectors that snap together and make electrical contact, slideconnectors that slide together to make electrical contact, or the like.

In further embodiments, one or more additional electrical contactfeatures 165 is located on the cap 4 (or other portion of thebase/reservoir/cap unit) for electrical contact with one or moreadditional electrical contact features 167 on the infusion pump device30, within the reservoir receptacle 32 of the infusion pump device 30,when the cap 4 (or base/reservoir/cap unit) is fully and properlyinstalled in the reservoir receptacle 32. The additional electricalcontact 167 on the infusion pump device 30 may be electrically connectedto the microcontroller 172 (or other portion of the electronics 170)through one or more electrical leads 169. In such embodiments, theelectronics (such as electrical circuit 170 and/or electrical circuit 60described above with respect to FIG. 5) may be configured to detect anelectrical connection of the additional electrical contact features 165and 167, in addition to or as an alternative to detection of anelectrical connection between the pairs of first and second electricalcontact features 161-164. In such embodiments, the electronics may beconfigured to verify a proper position of the cap 4 (orbase/reservoir/cap unit) within the reservoir receptacle 32, only upondetection of an electrical connection between the additional electricalcontact features 165 and 167, and also between the pairs of first andsecond electrical contact features 161-164. In other embodiments,detection of an electrical connection between the additional electricalcontact features 165 and 167, and a detection of an electricalconnection between the pairs of first and second electrical contactfeatures 161-164 may be employed as a redundant detection system.

In particular embodiments, the second electrical contact features 163and 164 are mounted on the housing 33 of the infusion pump device 30 andsealed with respect to the housing 33 in a manner that inhibits leakageof fluid (water or other fluid) through the housing 33. In suchembodiments, the infusion pump device 30 may be configured for use indamp conditions or, in further embodiments, in certain submerged orunderwater environments. For example, embodiments may be configured foruse in wet conditions (e.g., while the user is bathing, showering, orswimming), sea water or other salt water or ionic solution conditions,or high humidity or rain conditions. In such embodiments, a furtherreliable seal may be provided on the cap 4 (or base/reservoir/cap unit)or on the open end of the reservoir receptacle 32 of the infusion pumpdevice 30, or both, to inhibit fluid from entering into the reservoirreceptacle 32, when the cap 4 (or base/reservoir/cap unit is installedin the reservoir receptacle. Also in such embodiments, the rest of thehousing 33 of the infusion pump device may be made to be sufficientlysealed or water-tight, to inhibit water from entering the housing 33.Thus, in particular embodiments, each of the electrical connectionsbetween electrical contact features on the cap 4 (or base/reservoir/capunit) and contact features on the infusion pump device 30 are madeoutside of the reservoir receptacle 32 (e.g., via the pairs of first andsecond electrical contact features 161-164, where the second electricalcontact features 163 and 164 are sealed with the housing 33 to inhibitpassage of fluid through the contact features).

In particular embodiments, the electronics (such as electrical circuit170 and/or electrical circuit 60 described above with respect to FIG. 5)may be configured to detect a condition in which the infusion pumpdevice is present in a wet environment or in an ionic solutionenvironment. In such embodiments, the electronics may be configured toprovide a signal to and detect a response from the electronic device(e.g., the IC chip 168) on the cap 4 (or base/reservoir/cap unit), wherethe response is different in wet (or ionic solution) conditions relativeto dry conditions.

The electronics in the infusion pump device (such as electrical circuit170 and/or electrical circuit 60 described above with respect to FIG. 5)may be configured to read data from (and/or write data to) theelectronic device (e.g., the IC chip 168) on the cap 4 (orbase/reservoir/cap unit) as discussed above, when the infusion pumpdevice (and the connected cap 4 or base/reservoir/cap unit) are in a dryenvironment. In particular embodiments, the electronics may be furtherconfigured to detect the presence of the cap 4 (or base/reservoir/capunit) in an installed position, as discussed above, but is disabled fromreading or writing to the electronic device (e.g., the IC chip 168) onthe cap 4 (or base/reservoir/cap unit), when the infusion pump device(and the connected cap 4 or base/reservoir/cap unit) are in a wet orionic solution environment. In such embodiments, the electronics in theinfusion pump device may be configured to operate in accordance with theTable 3.

TABLE 3 Connection Environment Read Data Confirm Presence Wet No Yes DryYes Yes

In embodiments that operate in accordance with Table 3, data may be readfrom or written to the electronic device (e.g., the IC chip 168) on thecap 4 (or base/reservoir/cap unit), when the infusion pump device (andconnected cap 4 or base/reservoir/cap unit) are in a dry environment,for example, to system setup or other activities that typically occur indry environments. For example, data relating to the model number,cannula length, infusion set tubing length or other characteristics asdescribed herein may be read from the electronic device (e.g., the ICchip 168) on the cap 4 (or base/reservoir/cap unit) in a dryenvironment, to assist with initial or updated settings of the infusionpump device to allow proper priming or filing of the infusion set tubingand cannula and conduct other operations. Then, at a later time, theinfusion pump device may be located in a wet (or ionic solution)environment that could inhibit accurate reading and writing date from orto the electronic device on the cap 4 (or base/reservoir/cap unit), yetstill detect the presence of the cap 4 (or base/reservoir/cap unit) andcontinue to operate as previously set (initially or by update) if thepresence of the cap 4 (or base/reservoir/cap unit) is detected. Inparticular embodiments, upon detection of a wet (or ionic solution)environment, the electronics (such as electrical circuit 170 and/orelectrical circuit 60 described above with respect to FIG. 5) may beconfigured to inhibit operation of a read or write operation, asexposure of the electrical contact features 161-164 to moisture or ionicsolutions may cause communication bit errors to occur.

An example of a circuit configuration for detecting a wet (or ionicsolution) condition is shown in FIG. 26, where the electronic device(e.g., the IC chip 168) on the cap 4 (or base/reservoir/cap unit) isconnected, through the first and second electrical contact features161-164 to a ground terminal 176 and to a pair of input/output terminals(GPIO-1 and GPIO-2) of a microprocessor chip (e.g., corresponding to themicrocontroller 172). In that embodiment, the microcontroller 172 mayselectively transmit a test signal through the electrical contactfeatures 163 and 161 to the IC chip 168, and then receive a responsesignal back from the IC chip 168, where the response signal through theelectrical contact features 163 and 161, where the response signal has avalue or parameter that differs when the IC chip 168 is in a wet (orionic solution) environment than when the IC chip 168 is in a dryenvironment. The microcontroller 172 may be configured to detect theresponse signal and determine whether or not the IC chip 168 is in a wetor dry environment.

Another example of a circuit configuration that further operates todetect the attachment or detachment of a cap 4 (or base/reservoir/capunit) to the infusion pump device 30 is shown in FIG. 27. In theembodiment of FIG. 27, the microcontroller 172 includes further inputterminals INT and ADC-CHX and a further input/output terminal IO, wherethe electrical contact feature 163 is connected to the terminal IO andto one input of a comparator (the other input of the comparator beingconnected to a reference potential, and the output of the comparatorbeing connected to the INT input). In the embodiment in FIG. 27, whenthe cap 4 (or base/reservoir/cap unit) is installed such that the ICchip 168 is connected to the electrical contact features 163 and 164,through the electrical contact features 161 and 162, then the INT inputreceives a signal output from the comparator, indicating a weak or astrong load. However, when the cap 4 (or base/reservoir/cap unit) is notfully installed such that the IC chip 168 is not connected to theelectrical contact features 163 and 164, then the INT input receives asignal output from the comparator, indicating no load. Themicrocontroller 172 may be configured to detect the load condition anddetermine whether or not the IC chip 168 is connected (to detect whetheror not the cap 4 or base/reservoir/cap unit is fully installed).

3. Reservoir/Cap/Infusion-Set Units

In embodiments as described above, the connection interface 40 isconfigured to connect and interface the reservoir 1 with the infusionset 50 and with the infusion pump device 30, using releasable couplersincluding a first releasable coupler that removably attaches the cap 4to the base 2 (and, thus, to the reservoir 1) and a second releasablecouple that removably attaches the cap 4 to the infusion pump device 30.In particular examples of such embodiments, the cap 4 may be configuredto allow the cap 4 to be selectively and manually connected anddisconnected from a reservoir 1 and an infusion pump device 30, forexample, to allow the reservoir 1 to be stored, shipped, sold, orotherwise provided to a user (or healthcare provider or other authorizedperson), separate and independent of the infusion pump device, theconnection interface 40 and the infusion set 50, and then connected withthe cap 4 and infusion pump device by the user (or healthcare provideror other authorized person).

In further examples of such embodiments, the releasable couplers may beconfigured to allow the user (or healthcare provider or other authorizedperson) to replace a first reservoir 1 with a second reservoir 1 (or are-filled first reservoir 1) and continue to use the same connectioninterface 40, by allowing the cap 4 to be disconnected from the firstreservoir 1 and reconnected to the second reservoir 1 (or re-filledfirst reservoir 1). For example, the first reservoir 1 may be removedfrom the reservoir receptacle 32 of the infusion pump device 30 (e.g.,after the first reservoir 1 is fully or partially empty or otherwiseready for replacement), the cap 4 (or the cap 4 and base 2) is removedfrom the first reservoir 1 and then connected to a second reservoir 1.The second reservoir 1 is, then, installed in the reservoir receptacle32 of the infusion pump device 30. In this manner, the reservoir 1 maybe replaced, while the infusion set 50 remains secured to a patient(without withdrawing the needle 56 from the patient's skin).

In other embodiments as described with reference to FIGS. 28a -34, areservoir (201 or 301) and an infusion set (250 or 350) are assembled asa combined unit and stored, shipped, sold, or otherwise provided to auser (or healthcare provider or other authorized person), as anassembled unit. Such embodiments may include a connection interface thatconnects the infusion set (250 or 350) to the reservoir (201 or 301)permanently or other manner in which the connection is maintained in adesired manner.

In particular embodiments, the reservoirs 201 and 301 and infusion sets250 and 350 correspond to (and operate similar to) the reservoir 1 andinfusion set 50 described above, and are employed with an infusion pumpdevice 30 in a manner as described herein. However, in the embodimentsdescribed with reference to FIGS. 28A-34, a transfer guard 200 or 300 isfurther provided for interfacing the reservoir 201 with a supplycontainer (203 in FIG. 31), to allow a user (or healthcare provider orother authorized person) to fill the reservoir 201 or 301 (completely orpartially) with infusion media from the supply container 203, forexample, prior to installing (or re-installing) the reservoir 201 or 301into the infusion pump device 30.

Embodiments described with reference to FIGS. 28A-34 may be employedwith any one or more of the detection embodiments (magnetic detection,RF detection, mechanical detection and optical detection) describedabove. Thus, in further embodiments of FIGS. 28A-34, the reservoir 201or 301, or the cap 204 or 304 (or both the reservoir and the cap) isprovided with one or more detectable elements 42, as described above.

a. Twist and Lock Embodiment

Embodiments described with reference to FIGS. 28A-31 employ a transferguard 200 for interfacing the reservoir 201 with a supply container 203.The transfer guard 200 is a structure configured to interface thereservoir 201 with a supply container (a bottle, second reservoir orother container, for example, to fill or re-fill the reservoir 201 withfluidic media from the bottle, second reservoir or other container. Oncefilled (or re-filled), the reservoir 201 is separated from the transferguard 200 and, then, may be installed in an infusion pump device 30 andoperated as described above. Examples of transfer guards are describedin U.S. Pat. No. 8,356,644 titled “Transfer Guard System and Methods”,which is incorporated herein by reference in its entirety. Otherembodiments may employ other suitable transfer guard structures.

In the embodiment in FIGS. 28A-31 the transfer guard 200 includes agenerally cylindrical body 202 configured of a suitably rigid materialsuch as, but not limited to plastic, metal, ceramic, wood, paper or cardstock, composite material, or the like. The body 202 of the transferguard 202 has a first end 205 for interfacing with the infusion mediaport of the reservoir 201, and a second end 206 for interfacing with aninfusion media port of a supply container 203. In the embodiment ofFIGS. 28A-31, the first end 205 has an opening and a cavity with aninterior volume for receiving at least a portion of the infusion mediaport of the reservoir 201. Also in that embodiment, the second end 206has an opening and a cavity with an interior volume for receiving atleast a portion of the infusion media port of the supply container.

When the infusion media ports of the reservoir 201 and the supplycontainer 203 are received in the cavities at the first and second endsof the transfer guard 200, one or more hollow needles in the transferguard 200 connect the interior volume of the supply container in fluidflow communication with the interior volume of the reservoir 201. Inthat state, the reservoir piston may be withdrawn (pulled outwardrelative to the body of the reservoir 201), to create a sufficientpressure differential between the interior of the reservoir 201 and theinterior of the supply container, to draw infusion media from the supplycontainer, through the hollow needle(s) and into the reservoir 201.

Once the reservoir 201 is sufficiently filled, the supply container 203may be removed from the second end 206 of the transfer guard 200.Alternatively or in addition, the first end 205 of the transfer guard200 may be removed from the reservoir 201, for example by rotating thetransfer guard 200 about the axis AA relative to the reservoir 201 andthen pulling the transfer guard 200 and reservoir 201 apart along thedirection of the axis AA, as described below. The axis AA corresponds tothe longitudinal axis of the reservoir 201, as well as the longitudinalaxis of the container 203 and of the transfer guard 200, when thecontainer 203 and transfer guard 200 are connected to the port of thereservoir 201 in the arrangement shown in FIG. 31. The transfer guard200 may be configured to be disposed of after removal from the reservoir201. Alternatively, the transfer guard 200 may be configured to bere-connected to another or the same reservoir 201, after removal fromthe reservoir 201, for one or more further filling operations.

A cap 204 that connects to the infusion media port of the reservoir 201,and is rotatable around the axis AA relative to the reservoir 201 whenconnected to the port of the reservoir 201. As described herein, whenconnected to the reservoir 201, the cap 204 is rotatable at least to andbetween a first position (or fill position) as shown in FIGS. 29A and29B, and a second position (or deliver position) as shown in FIGS. 30Aand 30B.

In the embodiment of FIGS. 29A-31, the cap 204 has a generallycylindrical portion 208 that extends coaxially with the axis AA when thecap 204 is connected to the port of the reservoir 201. The cap 204includes a protruding rib 210 that extends around the axis AA on theouter surface of the generally cylindrical portion 208. The protrudingrib 210 fits into a correspondingly shaped groove 212 in the port of thereservoir 201, to secure the cap 204 to the reservoir 201, yet allow thecap 204 to rotate around the axis AA relative to the reservoir 201. Inother embodiments, two or more protruding ribs are provided on the outersurface of the cylindrical portion 208 of the cap 204, and acorresponding number (two or more) grooves 212 are provided in the portof the reservoir 201 for receiving the two or more ribs when the cap 204is connected to the port of the reservoir 201.

In particular embodiments, the cap 204 or the port of the reservoir 201(or both) is made of a material that has sufficient rigidity to securethe cap 204 to the reservoir 201 when the rib(s) 210 is in the groove(s)212, but is sufficiently flexible and resilient to allow the cap 204 tobe snapped into the port of the reservoir 201. In such embodiments,during assembly, the cylindrical portion 208 is configured to beinserted into the port of the reservoir 201 and pushed along thedirection of the axis AA, causing the rib(s) 210 to ride along andpartially compress against the inner surface of the port of thereservoir 201, until the rib(s) 210 engage the groove(s) 212 in the portof the reservoir 201 and then expand from their compressed state to fillor partially fill the groove(s) 212. In particular embodiments, the cap204 is configured to provide a snap sound or snap-like feel that isperceptible to a person assembling the cap 204 with the reservoir 201,when the rib(s) 210 engage the groove(s) 212. Once snapped into place,the rib(s) 210 can ride within the groove(s) 212 to allow the cap 204 torotate around the axis AA relative to the reservoir 201, while remainingconnected to the reservoir 201.

In embodiments shown in FIGS. 29A-31, one or more ribs 210 are providedon the cap 204 and one or more grooves 212 are provided in the port ofthe reservoir 201. In other embodiments, the relative locations of theribs and grooves are reversed such that one or more ribs is provided onthe port of the reservoir 201 and one or more grooves is provided on thecap 204. In yet other embodiments, each of the cap 204 and the port ofthe reservoir 201 includes at least one rib and at least one groove.

A channel 214 extends through the cylindrical portion 208 of the cap204, along the direction of the axis AA. The channel 214 is open on bothends 216 and 217. However, the channel 214 is sealed by a septum 118that is held by the cap 204, adjacent the end 216. In the embodiment inFIGS. 29A-31, the septum 218 is supported within the cap 204, in aposition adjacent, but recessed from the end 216 of the channel 214. Theseptum is made of a material that provides a fluid seal and, inparticular embodiments, an hermetic seal, to seal the channel 214, butthat can be pierced by the needle(s) in the transfer guard 200, when theport of the reservoir 201 is received within the first end 205 of thetransfer guard 201. In particular embodiments, the septum 218 is made ofa material that automatically reseals itself after a needle has piercedthe material and then is withdrawn from the septum.

The channel 214 has an opening 220 at a location along its longitudinaldimension, between the first and second ends 216 and 217 of the channel214. The opening 220 is arranged to align in fluid flow communicationwith an open end 221 of a further channel 222 in the port of thereservoir 201, when the cap 204 is connected to the reservoir and thecap 204 is rotated to the second position (or deliver position) as shownin FIGS. 30A and 30B. However, when the cap 204 is in the first position(or fill position) as shown in FIGS. 29A and 29B, the opening 220 is outof alignment and out of fluid flow communication with the channel 222 inthe port of the reservoir.

The channel 222 in the port of the reservoir 201 has a longitudinaldimension that extends in a direction transverse to the longitudinaldimension of the channel 214 and the axis AA when the cap 204 isconnected to the reservoir 201. In the embodiment in FIGS. 29A-31, thechannel 222 extends generally perpendicular to the channel 214, when thecap 204 is connected to the reservoir 201. The channel 222 is connectedin fluid flow communication with tubing 252 of the infusion set 250. Inparticular embodiments, the tubing 252 is connected to the reservoir 201(at the channel 222) permanently or other manner in which the connectionis maintained. In the embodiment of FIGS. 29A-31, the tubing 252 isconnected with an infusion needle, as described above with respect totubing 52 and infusion needle 56.

In particular embodiments, the open end 221 of the channel 222 is sealedby the cap 204 to inhibit the passage of fluid into or out of thechannel 222, when the cap is in the first position (or other positionsbetween the first and second position). In one example, the outersurface of the cylindrical portion 208 of the cap 204 is configured tofit sufficiently closely with the inner surface of the port of thereservoir 201 to seal the open end 221 of the channel 222, when the cap204 is in the first position (or other positions between the first andsecond position). In further examples, one or more seals or sealmaterial is arranged on the outer surface of the cylindrical portion 208of the cap 204, to seal the open end 221 of the channel 222, when thecap 204 is in the first position (or other positions between the firstand second position).

The cap 204 includes one or more extension arms 224 that extend over theport end of the reservoir 201, when the cap 204 is connected to thereservoir 201. In the embodiment of FIGS. 29A-31, the cap 204 has twoextension arms 224 extending from the cylindrical portion 208 of the cap204. The extension arms 224 extend from the cylindrical portion 208 atlocations opposite each other (180 degree apart) relative to the axis AAand are thinner than the cylindrical portion 208 in the dimension of theaxis AA. Accordingly, when the cap 204 is connected to the port of thereservoir 201, the arms 224 extend outward and transverse to the axisAA, over the port end of the reservoir 201, as shown in FIGS. 29A-30B.

The port of the reservoir 201 also includes one or more extension arms226 that extend outward and transverse to the axis AA. In the embodimentof FIGS. 28A-31, the reservoir 201 has two extension arms 226 extendingfrom the port end of the reservoir 201, at locations opposite each other(180 degree apart) relative to the axis AA. The extension arms 226 onthe port of the reservoir 201 are arranged to align with the extensionarms 224 (such that extension arms 224 are directly on top of theextension arms 226 in the direction of the axis AA) when the cap 204 isrotated to the second position (or deliver position) as shown in FIGS.30A and 30B. The extension arms 226 are arranged to not align with theextension arms 224 (such that extension arms 224 are not directly on topof the extension arms 226 in the direction of the axis AA) when the cap204 is in the first position (or fill position) as shown in FIGS. 29Aand 29B, or when the cap 204 is in other positions between the first andsecond positions. As described herein, the extension arms 224 providesurfaces that can be engaged to receive a force for rotating the cap 204from a first position (or fill position) as shown in FIGS. 29A and 29B,to a second position (or deliver position) as shown in FIGS. 30A and30B.

In particular embodiments, the cap 204 or the port of the reservoir 201(or both) are provided with a latch or other structure that locks thecap 204 in the second position (or deliver position), after the cap 204has been rotated to the second position. In the embodiment in FIGS.29A-31, the cap includes a pair of flexible pawls 228 that are arrangedto engage a corresponding pair of stop members 230 on the port of thereservoir 201. In particular embodiments, the flexible pawls 228 areflexible extensions of the cap 204, formed as a unitary (for example,molded) structure with the cylindrical portion 208 and the arms 224 ofthe cap 204. The flexible pawls 228 are arranged around the outerperiphery of the cylindrical portion 208 of the cap 204, to rideadjacent an end surface of the port of the reservoir 201, as the cap 204is rotated in a first direction (for example, clockwise) between thefirst position (or fill position) and the second position (or deliverposition).

The stop members 230 are arranged on that end surface of the port of thereservoir 201, to engage the flexible pawls 228, as the cap 204 isrotated in the first direction between the first position (or fillposition) and the second position (or deliver position). As the cap 204is rotated from the first position (or fill position) toward the secondposition (or deliver position), the flexible pawls 228 engage and slidealong the stop members 230. The engagement with the stop members 230causes the flexible pawls 228 to flex inward toward the axis AA as theyride along the stop members 230. As the cap 204 is rotated to the secondposition (or deliver position), the flexible pawls 228 are moved pastthe stop members 230 and flex back outward, away from the axis AA, dueto their natural resilience.

In particular embodiments, the stop members 230 are shaped or otherwiseconfigured to inhibit rotation of the cap 204 out of the second position(or deliver position), once the cap 204 has been rotated to thatposition. In the embodiment of FIGS. 29A-31, each stop member 230 has asloping or ramp surface that that faces a flexible pawl 228 when the cap204 is in the first position (or fill position) and a stop surface thatfaces the flexible pawl 228 when the cap 204 is in the second position(or deliver position). The sloping or ramp surface of the stop member230 slopes inward toward the axis AA in the direction of cap rotationfrom the first position to the second position, while the stop surfaceof the stop member 230 has a more abrupt radial dimension. In otherembodiments, each stop member 230 has other shapes suitable for allowingthe flexible pawls 228 to pass as the cap 204 is rotated toward thesecond position (or deliver position) and to engage the flexible pawls228 to inhibit reverse rotation of the cap 204 toward the first position(or fill position) once the cap 204 has been rotated to the secondposition. In the embodiment in FIGS. 29A-31, the cap 204 is providedwith two flexible pawls 228 and the reservoir 201 is provided with twostop members 230. In other embodiments, the cap 204 is provided withonly one flexible pawl or with more than two flexible pawls, thereservoir 201 is provided with only one stop member or with more thantwo stop members, or any combination thereof.

In the embodiment of FIGS. 28A-31, the transfer guard 200 includes awindow opening 232 for each extension arm 226 of the reservoir 201.Accordingly, in the embodiment of FIGS. 28A-31, the transfer guard 200has two window openings 232. In addition, a slot 234 is provided at ornear one side edge 236 of each window opening 232. Each slot 234 extendsparallel to the direction of the axis AA, from one of its windowopenings 232 to the first end 205 of the transfer guard 200. The windowopenings 232 and the slots 234 open to the reservoir-receiving cavity inthe first end 205 of the transfer guard 200, such that, when the port ofthe reservoir 201 is received within the cavity in the first end 205 ofthe transfer guard, each extension arm 226 on the port of the reservoir201 extends through a respective one of the window openings 232.

In the embodiment of FIGS. 28A-31, the reservoir 201, infusion set 250and transfer guard 200 may be assembled together as a single unit, andpackaged, stored, and provided to a user (or healthcare provider orother authorized person) as a pre-assembled unit(reservoir/infusion-set/transfer-guard unit). Initially, the cap 204 isin the first position (or fill position) as shown in FIGS. 29A and 29B,but with the port of the reservoir 201 received within the first end 205of the transfer guard 200 as shown in FIGS. 28A and 28B. In that state,the extension arms 224 of the cap 204 and the extension arms 226 of thereservoir 201 extend through the openings 232 in the transfer guard 200,but with the extension arms 226 out of alignment with the slot 234.

With the port of the reservoir received within the first end 205 of thetransfer guard 200 and the cap 204 in the first position (or fillposition), a supply container that contains a supply of infusion mediamay be received in the cavity in the second end 206 of the transferguard 200. In particular embodiments, thereservoir/infusion-set/transfer-guard unit is provided to a user (orhealthcare provider or other authorized person) in a pre-assembledstate, but without a supply container connected to the transfer guard200. In such embodiments, the reservoir 201 may be filled (partially orfully) before installation in an infusion pump device, by installing asupply container in the second end 206 of the transfer guard 200 andwithdrawing (partially or fully) the piston in the reservoir 201 to drawa desired volume of infusion media fluid from the supply container,through the transfer guard needle(s), and into the reservoir 201. Oncethe reservoir 201 has received the desired volume of infusion mediafluid, the user (or healthcare provider or other authorized person)releases the reservoir 201 from the transfer guard 200 and installs thereservoir 201 into the reservoir receptacle 32 of the infusion pumpdevice 30, for operation as described above.

In particular embodiments, to release the reservoir 201 from thetransfer guard, the user (or healthcare provider or other authorizedperson) rotates one of the transfer guard 200 and reservoir 201 relativeto the other in a first direction (for example, the clockwise in theembodiment of FIG. 28A) about the axis AA, to a release position (shownin FIG. 28B). As the transfer guard 200 and reservoir 201 are rotatedrelative to each other, the side edge 236 of each window opening 232engages one of the arms 224 of the cap 204 and applies a force on thearm 224. Further relative rotation of the transfer guard 200 andreservoir 201 in the first direction forces the arms 224 to rotate thecap 204 toward and to the second position (or deliver position) shown inFIGS. 30A and 30B.

When the cap 204 reaches the second position (or deliver position), thearms 224 are aligned with (adjacent and directly on top of) theextension arms 226 on the port of the reservoir 201. In addition, thealigned arms 224 and 226 are aligned with the slots 234 in the transferguard. In that state, the reservoir 201 may be withdrawn from thetransfer guard 200, by manually separating the reservoir 201 from thetransfer guard 200 in the direction of the axis AA, as shown by thearrow in FIG. 28B. As the reservoir 201 is withdrawn from the transferguard 200, the aligned extension arms 224 and 226 pass through the slots234, to allow the port of the reservoir 201 to be removed from thecavity in the first end 205 of the transfer guard 200. Upon removal fromthe transfer guard 200, the cap 204 in the port of the reservoir 201 isin the second position (or deliver position) as shown in FIGS. 30A and30B. Thus, rotation of the transfer guard 200 and reservoir 201 relativeto each other to a release position (FIG. 28B) also causes the cap 204to rotate to the second position (or deliver position).

Accordingly, in particular embodiments, thereservoir/infusion-set/transfer-guard unit is provided with the cap 204in a first position (or fill position) in which the fluid pathway to theinfusion set 250 is closed, to prevent introduction of air. In thatstate, a supply container may be connected to the transfer guard 200 tofill (partially or fully) the reservoir 201. Once the reservoir isfilled to a desired level, the transfer guard is used to assist rotationof the cap 204 to the second position (or deliver position), in whichthe fluid pathway to the infusion set 250 is opened to the interior ofthe reservoir 201. In particular embodiments, the cap 204 is latched orlocked into the second position (or deliver position), once it isrotated to that position. In that state, the reservoir 201 is removedfrom the transfer guard 200 and is installed in the reservoir receptacle32 of the infusion pump 30 for operation as described above.

Embodiments described with reference to FIGS. 28A-31 may be employedwith any one or more of the detection embodiments (magnetic detection,RF detection, mechanical detection and optical detection) describedabove. In such embodiments, the reservoir 201 or cap 204 (or both) isprovided with one or more detectable elements 42 described above, asshown in FIG. 31.

In particular examples of such embodiments, one or more detectableelements is arranged on one or more extension arms 224 of the cap 204,and one or more corresponding sensors is arranged on the infusion pumpdevice 30 at locations to detect whether or not the extension arm 224has been sufficiently rotated to the second position (or deliverposition). In such embodiments, electronics 60 in the infusion pumpdevice may be configured to provide one or more predefined operations,upon the detection of an extension arm 224 that is not sufficientlyrotated to the second position (or deliver position), where suchpredefined operations include, but are not limited to one or more ofstopping or inhibiting pumping operation, allowing only a limitedpumping operation, providing a warning message, or recording dataindicating the detection. Alternatively or in addition, the electronics60 may be configured to provide one or more predefined operations, atleast partially based on (or in response to) a determination that theextension arm 224 is properly rotated to the second position, where suchpredefined operations include, but are not limited to one or more ofallowing or providing pumping operation, allowing a predefined pumpingoperation, providing a predefined message, and recording data indicatingthe detection.

b. Spring-Loaded Plunger

Embodiments described with reference to FIGS. 32-34 employ a transferguard 300 for interfacing the reservoir 301 with a supply container(e.g., similar to supply container 203 discussed above). FIG. 32 show apartial cross-section view of a neck portion of the reservoir 301received within (and interfacing with) a portion of the transfer guard300. FIG. 33 shows a partial cross-section view of the neck portion ofthe reservoir 301, when the transfer guard 300 is detached and removedfrom the neck portion. FIG. 34 shows an exploded, perspective view ofthe reservoir, cap and transfer guard system. Only a portion of thetransfer guard 300 (i.e., the first end 305 portion, including a portionof a hollow needle 306) is shown in FIG. 32.

In the embodiment of FIGS. 32-34, the reservoir 301 has an infusionmedia port arranged within a neck portion 307 of the reservoir 301. Inaddition, a cap structure 310 is arranged within the neck portion 307 ofthe reservoir 301. The cap structure 310 includes a moveable plunger 312and a bias member 314, such as, but not limited to, a coil spring orother spring structure.

The neck portion 307 of the reservoir 301 includes a channel 316 that isopen on one end to the interior volume of the neck portion 307 and isconnected at its other end to tubing 352 of an infusion set 350. Inparticular embodiments, the tubing 352 is connected to the reservoir 301(at the channel 316) permanently or other manner in which the connectionis maintained. The infusion set 350 and tubing 352 may be similar to theinfusion set 50 or 250 and tubing 52 or 252 described above.

The neck portion 307 of the reservoir 301 also includes one or morefirst projections or other stop surfaces 318 and one or more second stopsurfaces 320 arranged to hold the moveable plunger 312 within theinterior volume of the neck portion 307. In particular embodiments, thefirst projection or stop surface 318 includes a ring-shaped projectionarranged at or adjacent the bottom of the neck portion 307 (where theinterior volume of the neck portion 307 opens into the rest of theinterior volume of the reservoir). In particular embodiments, the secondprojection or stop surface 320 includes a ring-shaped projectionarranged at or adjacent the reservoir port or top of the neck portion307 (where the interior volume of the neck portion 307 opens to theenvironment outside of the reservoir). In particular embodiments, thefirst and second projections or stop surfaces 318 and 320 are formedintegral with the body of the reservoir 301, for example, as a unitarymolded structure. In other embodiments, the one or both of the first andsecond projections or stop surfaces 318 and 320 is formed as a separateelement that is fixed to the reservoir 301.

In the embodiment in FIGS. 32-34, the moveable plunger 312 includes agenerally cylindrical shaped body having first and second opposedsurfaces 322 and 324. The first surface 322 faces upward in FIGS. 32-34,toward the open end in the port of the reservoir 301. The second surface324 faces downward in FIGS. 32-34, toward the interior volume of thereservoir 301. The plunger 312 includes one or more fluid flow passagesthat allow fluid to pass through the plunger 312. In the embodiment ofFIGS. 32-34, four fluid flow passages 326 are provided in the form ofchannels extending through the plunger 312 (from the side of the firstsurface 322 to the side of the second surface 324). In otherembodiments, any suitable number of channels or other fluid flowpassages are provided through the moveable plunger 312. The moveableplunger 312 may be made of any suitable material having sufficientrigidity and strength to operate in the manner described herein, suchas, but not limited to plastic, rubber, metal, ceramic, wood orcomposite material, or any combination thereof.

Similar to embodiments described above, the reservoir 301, infusion set350 and transfer guard 300 in the embodiment of FIGS. 32-34 may beassembled together as a single unit, and packaged, stored, and providedto a user (or healthcare provider or other authorized person) as apre-assembled unit (reservoir/infusion-set/transfer-guard unit). Inother embodiments, the reservoir 301 and transfer guard 300 are providedseparately, and then assembled together, at or before use.

When the transfer guard 300 is assembled with the reservoir 301, theport portion of the reservoir 301 is received within a cavity at thefirst end 305 of the transfer guard 300, and the transfer guard needle306 is received within the open end of the port of the reservoir 301, asshown in FIG. 32. In that state, the transfer guard needle 306 engagesthe first surface 322 of the plunger 312 and applies a force on theplunger that overcomes the bias force of the bias member 314, to pushthe plunger 312 into a first position (or a fill position), as shown inFIG. 32. In the embodiment of FIGS. 32-34, the surface 322 of theplunger 312 has a central region 323 that is spaced from the flowpassages 326 and provides an engagement surface for engaging thetransfer guard needle 306.

In the first position (or fill position), the cylindrical outer surfaceof the plunger 312 is aligned with the open end of the channel 316, toblock fluid flow to or from the channel 316, to seal the channel 316.However, the flow passages 326 in the plunger 312 allow fluid to passthrough the plunger 312, and into the interior volume of the reservoir301. Accordingly, in the first position (or fill position) shown in FIG.32, the plunger 312 blocks the channel 316 to inhibit fluid from passinginto or out of the infusion set tubing 352, yet allows fluid to flowfrom the needle 306 of the transfer guard 300, through the flow passages326 and into the interior of the reservoir, to fill (partially or fully)the reservoir.

In one example, the outer surface of the plunger 312 is configured tofit sufficiently closely with the inner surface of the neck of thereservoir 201 to seal the open end of the channel 316, when the plunger312 is in the first position. In further examples, one or more seals orseal material is arranged on the outer cylindrical surface of theplunger 316, to seal the open end of the channel 316, when the plunger316 is in the first position. In such embodiments, the one or more sealsor seal material may include, for example, but not limited to, asilicone or soft plastic or rubber material affixed to the outercylindrical surface of the plunger 316, at a location to align with andblock or seal against the open end of the channel 316.

After filling of the reservoir 301, the port end of the reservoir 301 isremoved from the transfer guard 300, so that the reservoir 301 may beinstalled within a reservoir receptacle 32 of an infusion pump device 30as described above. Upon removal of the reservoir 301 from the transferguard 300, the transfer guard needle 306 is withdrawn from the port ofthe reservoir 301. This allows the moveable plunger 312 to move, underthe force of the bias member 314 toward its second position (or deliverposition) shown in FIG. 33. In the second position (or deliverposition), the plunger 312 abuts against the second stop surface 320.

In the second position (or deliver position), the plunger 312 isseparated from the open end of the channel 316, to allow fluid flowcommunication between the channel 316 and the interior of the reservoir301. As a result, the infusion set tubing 352 of the infusion set 350 isin flow communication with the interior of the reservoir, to allow fluiddelivery. In this state, the reservoir 301 may be installed in thereservoir receptacle 32 of an infusion pump device 30 and operated asdescribed above.

Accordingly, in the embodiment of FIGS. 32-34, the reservoir 301,infusion set 350 and transfer guard 300 may be provided as an assembledunit, where the needle of the transfer guard forces the plunger to afirst position (or fill position) against the bias force of the biasmember. In that first position (or fill position), the plunger seals thechannel 316 and, thus, closes off the fluid flow path between theinterior of the reservoir and the infusion set before and during afilling operation. The flow passages 326 in the plunger 312 allow fluidto flow from the transfer guard needle (from a supply container), intothe interior of the reservoir 301, when the plunger 312 is in the firstposition (or fill position). Once filling is sufficiently complete, thereservoir 301 is removed from the transfer guard 300, causing the biasedplunger 312 to move to the second position (or deliver position), wherethe plunger 312 no longer seals the channel 316. In that position, thechannel 316 is in fluid flow communication with the interior of thereservoir 301, and the reservoir 301 is installed in an infusion pumpdevice 30 for controlling delivery of infusion media to the infusion settubing 352, through the channel 316.

In further examples of the embodiments of FIGS. 32-34, the reservoir 301includes a septum (not shown) at or adjacent the open port end of thereservoir, for sealing the open port end of the reservoir. The septum(not shown) may be made of any suitable material, such as, but notlimited to a silicone, plastic or rubber material, that is compatiblewith infusion media contained within the reservoir 301 and that can bepierced by the needle 306 (and through which the needle 306 extends)when the transfer guard 300 is connected to the neck portion of thereservoir 301. In particular embodiments, the septum (not shown) has adisk or plug shape configured to fit within the neck portion of thereservoir 301, and is secured to the neck portion of the reservoir 301(for example, secured to the second stop surface 320. In particularembodiments, the septum is made of a re-sealable material that sealsitself after removal of the needle 306.

Embodiments described with reference to FIGS. 32-34 may be employed withany one or more of the detection embodiments (magnetic detection, RFdetection, mechanical detection and optical detection) described above.In such embodiments, the reservoir 301 or plunger 312 (or both) isprovided with one or more detectable elements 42 described above, asshown in FIG. 32.

In particular examples of such embodiments, one or more correspondingsensors is arranged on the infusion pump device 30 at locations todetect whether or not the plunger 312 has moved to the second position(or deliver position). In such embodiments, electronics 60 in theinfusion pump device may be configured to provide one or more predefinedoperations, upon the detection that the plunger 312 has not sufficientlymoved to the second position (or deliver position), where suchpredefined operations include, but are not limited to one or more ofstopping or inhibiting pumping operation, allowing only a limitedpumping operation, providing a warning message, or recording dataindicating the detection. Alternatively or in addition, the electronics60 may be configured to provide one or more predefined operations, atleast partially based on (or in response to) a determination that theplunger 312 has sufficiently moved to the second position (or deliverposition), where such predefined operations include, but are not limitedto one or more of allowing or providing pumping operation, allowing apredefined pumping operation, providing a predefined message, andrecording data indicating the detection.

4. Mechanical Interface of Cap or Reservoir with Pump

As described above, the second releasable coupler releasably secures thecap 4 (or base/reservoir/cap unit) to the housing of the infusion pumpdevice 30, when the base/reservoir/cap unit is received in the reservoirreceptacle 32 of the infusion pump device 30. In the embodiment of FIGS.1 and 2, the second releasable coupler includes threads 19 on thehousing 5 of the cap 4 that are arranged to engage corresponding threads(not shown) in a reservoir receptacle 32 of the infusion pump device 30in order to releasably secure the base/reservoir/cap unit to theinfusion pump device 30.

In other embodiments, the second releasable coupler includes othersuitable coupling structures for coupling the cap 4 to the infusion pumpdevice 30 in a selectively releasable manner, such as, but not limitedto the coupling structures described with reference to FIGS. 35-75. Theembodiments described with reference to FIGS. 35-75 and 78-81 includecaps 404, 504, 704, 804, 904 a-e, 964, 974, 984, 994, 1004 and 1014,that connect to reservoirs 1 (e.g., to form base/reservoir/cap units asdescribed above) and that are received in reservoir receptacles 32 andoperate with infusion pump devices 30 in a manner similar to thatdescribed above with respect to cap 4.

Embodiments described with reference to FIGS. 35-75 and 78-81 may beemployed with any one or more of the detection embodiments (magneticdetection, RF detection, mechanical detection and optical detection)described above. Thus, in further embodiments of FIGS. 35-75, thereservoir or the cap 404, 504, 704, 804, 904 a-e, 964, 974, 984, 994,1004 and 1014 (or both) is provided with one or more detectable elements42, as described above.

a. Push-Fit, Pinch Release on Cap

In particular embodiments, the second releasable coupler includes one ormore resilient extensions that engage stop surfaces in the reservoirreceptacle 32 to retain the cap (or base/reservoir/cap unit) within thereservoir receptacle. The one or more resilient extensions are flexibleto selectively disengage the stop surfaces sufficiently to allow removalof the cap (or base/reservoir/cap unit) from the reservoir receptacle32.

For example, in the embodiment described with reference to FIG. 35, thesecond releasable coupler includes two flexible, resilient extensions(arms or wings) 406 on the cap 404. The extensions 406 are configured tobe received with a channel 35 in the reservoir receptacle 32, as shownin FIG. 35. When engaged with the channel 35, the resilient extensions406 inhibit removal of the cap 404 (or base/reservoir/cap unit) from thereservoir receptacle 32 of the infusion pump device 30. However, fromthe state shown in FIG. 35, the two extensions 406 may be manuallysqueezed toward each other (for example, by placing a thumb and firstfinger on different respective ones of the two extensions 406 andsqueezing the extensions toward each other), to withdraw the extensions406 from the channel 35 by a sufficient amount to allow the user to pullthe cap 404 (or base/reservoir/cap unit) out of the reservoir receptacle32.

In the embodiment of FIG. 35, the cap 404 is configured to be coupled toa reservoir (or base and reservoir) as described above with respect tocap 4, base 2 and reservoir 1. The drawing in FIG. 35 shows a cut-awayview of the cap 404 and a portion of the reservoir receptacle 32 of theinfusion pump device 30, without the base and reservoir, to betterillustrate the manner in which the cap 404 engages the housing of theinfusion pump device 30. However, in particular embodiments, the cap 404is configured to be received within the reservoir receptacle 32, whenthe cap 404 is already assembled with the reservoir 1 (for example, aspart of a base/reservoir/cap unit as described above).

The cap 404 includes a port 408 for connection with an infusion settubing such as, but not limited to, an infusion set tubing 52 of aninfusion set 50 as described above. The cap 404 also includes a bodyportion 407 through which a channel 409 extends. The channel 409connects to a hollow needle (not shown) similar to needle 9 describedabove, and provides a fluid flow communication path from the hollowneedle to the port 408 (and to an infusion set tubing, when connected tothe port 408). The cap 404 also includes one or more connection features(of the first releasable coupler) for coupling the cap 404 to areservoir (or to a base/reservoir unit). In the embodiment in FIG. 35,the connection features include detent openings 410 (similar to detentopenings 10 described above), entry slots 415 (similar to entry slots 15described above) and a stop shoulder 416 (similar to the stop shoulder16 described above). Connection features 410, 415 and 416 may beconfigured and may operate to connect the cap 404 to a reservoir 1 (orbase/reservoir unit) in a manner similar to openings 10, slots 15 andstop shoulder 16 described above.

The cap 404 may be made of any one or more suitable materials havingsufficient rigidity and strength to operate as described herein,including, but not limited to plastic, metal, ceramic, composite orother suitable material. In one example, the cap 404 (including theresilient extensions 406, body 407 and port 408) is made of a moldedplastic material, as a single, unitary, molded structure. In otherembodiments, the cap 404 may be made by other processes or in multipleparts that are assembled together (or both).

In the embodiment shown in FIG. 35, each of the resilient extensions 406has an engagement portion 406 a. The engagement portion 406 a of eachextension 406 is shaped to be at least partially received within thechannel 35 in the reservoir receptacle 32 of the infusion pump device30, when the cap 404 (or base/reservoir/cap unit) is installed in thereservoir receptacle 32. When received within the channel 35, theengagement portions 406 a of the resilient extensions 406 inhibitremoval of the cap 404 (or base/reservoir/cap unit) from the reservoirreceptacle 32 of the infusion pump device 30. However, when engaged withthe channel 35, the two extensions 406 may be manually squeezed towardeach other (for example, by placing a thumb and first finger ondifferent respective ones of the two extensions 406 and squeezing theextensions toward each other), to withdraw the engagement portions 806 afrom the channel 35 by a sufficient amount to allow the user to pull thecap 404 (or base/reservoir/cap unit) out of the reservoir receptacle 32.

The channel 35 defines a lip portion 37 around the rim of the open endof the reservoir receptacle 32, where the channel 35 and the lip portion37 have a first stop surface 35 a (the downward-facing surface of thechannel 35 in FIG. 35) against which a first surface of each engagementportion 406 a (the upward-facing surfaces of the extensions 406 in FIG.35) engages to inhibit removal of the cap 404 from the reservoirreceptacle 32, when the engagement portions 406 a of the extensions arereceived in the channel 35. A second stop surface 35 b (the upwardfacing surface of the channel 35 in FIG. 35) against which a secondsurface of each engagement portion 406 a engages to inhibit furtherinsertion of the cap 404 (or base/reservoir/cap unit) further into thereservoir receptacle 32, once the engagement portions 406 a of theextensions are received in the channel 35.

In particular embodiments, the cap 404 is provided to the user (ormedical technician or other authorized person) either separate from orconnected to a reservoir 1. If received separately, the user (or medicaltechnician or other authorized person) assembles the cap 404 with thereservoir 1 (or with the base 2 and reservoir 1 to form abase/reservoir/cap unit) as described above.

Once assembled, the base/reservoir/cap unit is inserted into thereservoir receptacle 32, along the direction of the axis A. Inparticular embodiments, while inserting the base/reservoir/cap unit intothe reservoir receptacle 32, the user (or medical technician or otherauthorized person) squeezes the extensions 406 inward in the radialdirection, toward each other (or toward the axis A). With the extensions406 squeezed inward sufficient to allow the engagement portions 406 a toclear the lip 37 of the port of the reservoir receptacle 32, the user(or medical technician or other authorized person) inserts thebase/reservoir/cap unit into the reservoir receptacle 32. Once theengagement portions 406 a are inserted past the lip 37, the user (ormedical technician or other authorized person) releases the squeezingforce on the extensions 406, to allow the extensions 406 to move backoutward in the radial direction toward their pre-squeezed state.

As the extensions 406 return toward their pre-squeezed state, theengagement portions 406 a move outward in a radial direction relative tothe axis A to engage the inner surface of the reservoir receptacle 32.Then, if needed, the user (or medical technician or other authorizedperson) can make adjustments to the position of the cap 404 in thedirection of the axis A to align the engagement portions 406 a with thechannel 35, to allow the engagement portions to be received within thechannel 35. As the engagement portions 406 a align with the channel 35,the resilient return force of the extensions 406 causes the engagementportions 406 a to move into the channel 35 and lock the cap 404 (andbase/reservoir/cap unit) to the reservoir receptacle 32 of the infusionpump device 30.

Thus, in particular embodiments, the user (or medical technician orother authorized person) squeezes the extensions 406 toward each otherwhen inserting the cap 404 (or base/reservoir/cap unit) into thereservoir receptacle 32. In other embodiments, the engagement portions406 a are shaped to allow the user (or medical technician or otherauthorized person) to insert the cap 404 (or base/reservoir/cap unit)into the reservoir receptacle 32 without the user also applying aseparate squeezing force on the extensions 406. For example, in suchembodiments, the engagement portions 406 a may be rounded or angled attheir tip, to allow the movement of the cap 404 (or base/reservoir/capunit) along the axis A into the reservoir receptacle 32 to force theextensions toward each other.

In particular embodiments, the resilient return force of the extensions406 and the shape of the engagement portions 406 a are configured toprovide a snap-fit action between the engagement portions 406 a and thechannel 35. In such embodiments, the extensions 406 and the shape of theengagement portions 406 a are configured to provide an audible ortactile (or both) snap sound or feel (or both) that is perceptible tothe user (or medical technician or other authorized person) as the user(or medical technician or other authorized person) inserts the cap 404(or base/reservoir/cap unit) into the reservoir receptacle 32. Thesnap-fit action provides the user (or medical technician or otherauthorized person) with an audible or tactile (or both) indication thatthe cap 404 (or base/reservoir/cap unit) has been sufficiently orproperly received within the reservoir receptacle 32.

The cap 404 (or base/reservoir/cap unit) may be removed from thereservoir receptacle 32 by squeezing the two extensions 406 toward eachother to withdraw the engagement portions 806 a from the channel 35 by asufficient amount to allow the user to pull the cap 404 (orbase/reservoir/cap unit) out of the reservoir receptacle 32. With theextensions 406 squeezed toward each other, the user (or medicaltechnician or other authorized person) pulls the cap 404 (orbase/reservoir/cap unit) in the direction of the axis A, out of thereservoir receptacle 32. In particular embodiments, no twisting orrotational motion on the cap 404 is needed to remove the cap 404 (orbase/reservoir/cap unit) from the reservoir receptacle 32.

In the embodiment of FIG. 35, each extension 406 has a squeeze surface406 b that is exposed or otherwise accessible to the user (or medicaltechnician or other authorized person) when the cap 404 (orbase/reservoir/cap unit) is installed in the reservoir receptacle 32. Inparticular embodiments, the surfaces 608 b are located outside of andabove the port of the reservoir receptacle 32 when the cap 404 (orbase/reservoir/cap unit) is installed in the reservoir receptacle 32.The surfaces 406 b are provided for a user (or medical technician orother authorized person) to grip or otherwise operate the extensions 406to selectively squeeze and release the extensions, and to pull the cap404 (or base/reservoir/cap unit) in the direction of the axis A, out ofthe reservoir receptacle 32, as described above. In particularembodiments, the surfaces 406 b have a friction enhancing feature, toimprove the grip of the user (or medical technician or other authorizedperson) and to provide a tactile indication to the user (or medicaltechnician or other authorized person) of the surface 406 b. In theillustrated embodiment, the friction enhancing feature includes aplurality of ridges or grooves formed in the surfaces 406 b. In otherembodiments, other suitable friction enhancing features are provided onthe surfaces 406 b such as, but not limited to, other patterns of raisedor recessed surface contours, a layer of rubber or other material ofhigher friction than the material of the extensions 406, or the like.

In particular embodiments, the reservoir receptacle 32 of the infusionpump device 30 includes a spring or other bias member that imparts abias force on the cap 404 or the reservoir 1 in the direction of theaxis A and outward from the reservoir receptacle 32, when thebase/reservoir/cap unit is installed in the reservoir receptacle 32. Inone example embodiment, the infusion pump device 30 includes a coilspring located at the bottom of the reservoir receptacle 32, to impart abias force on the reservoir 1 and the cap 404 in the upward directionwith respect to FIG. 35, when the base/reservoir/cap unit is installedin the reservoir receptacle 32. In other embodiments, the bias memberincludes a spring located to engage a predefined surface of the cap 404when the base/reservoir/cap unit is installed in the reservoirreceptacle 32. In yet further embodiments, the bias member is a springor other bias device attached to the cap 404 or to the reservoir 1, toengage a predefined surface in the reservoir receptacle 32 of theinfusion pump device when the base/reservoir/cap unit is installed inthe reservoir receptacle 32. The bias force causes the first surface(upper surface in FIG. 35) of the engagement portion 406 a to pressagainst the first stop surface 35 a of the channel 35. In suchembodiments, the bias force helps to lock and maintain the cap 4 (andbase/reservoir/cap unit) in a predefined position within the reservoirreceptacle 32.

In the embodiment shown in FIG. 35, the cap 404 has two resilientextensions 406 arranged on opposite sides of the axis A relative to eachother (e.g., about 180 degrees apart). In other embodiments, the twoextensions 406 may be arranged at other suitable locations relative tothe each other and the axis A. In yet other embodiments, the cap 404includes only one resilient extension 406. In yet other embodiments, thecap 404 includes more than two resilient extensions 406. For example, ina further embodiment, the cap 404 includes four resilient extensions 406arranged in two pairs, such that two hands are used to squeeze all fourof the extensions (i.e., one hand for squeezing two of the fourextensions, and the other hand for squeezing the other two extensions).

In various embodiments described above, the resilient extensions 406 areformed integral with the body 407 of the cap 404 and are made of amaterial having a natural flexibility and resilience. In otherembodiments, the extensions 406 are separate members that are attachedto the body 407 of the cap 404 with resilient connectors, such as, butnot limited to springs or material having a natural spring force.

In the embodiment of FIG. 35, channel 35 is an annular channel in thehousing of the infusion pump device 30 (or a housing portion 33, 33′,33″ as described above). The channel 35 is located within the reservoirreceptacle 32, a small distance from the open end of the reservoirreceptacle 32 and extends around the axis A of the cap 404 (orbase/reservoir/cap unit), when the cap 404 (or base/reservoir/cap unit)is located within the reservoir receptacle 32. The annular shape of thechannel 35 allows the cap 404 to be inserted into the reservoirreceptacle 32 in any rotational orientation (about the axis A) relativeto the infusion pump device 30, and still allow the engagement portions406 a to align with and engage the first and second stop surfaces of thechannel. However, other suitable configurations of one or more stopsurfaces may be employed in other embodiments. For example, otherembodiments may employ stop surfaces formed by surfaces of one or moreindentations or recesses in the inner surface of the reservoirreceptacle 32, at locations for receiving one or more engagementportions 406 a, instead of surfaces of an annular channel. Yet otherembodiments, one or more of the stop surfaces is provided by one or moreraised features on the inner surface of the reservoir receptacle 32.

Embodiments described with reference to FIG. 35 may be employed with anyone or more of the detection embodiments (magnetic detection, inductivedetection, RF detection, mechanical detection, optical detection andelectrical contact detection) described above. In such embodiments, thecap 404 or the reservoir 1 (or both) is provided with one or moredetectable elements 42 described above.

In particular examples of such embodiments, one or more detectableelements 42 is provided on one or each extension 406. For example, oneor more detectable elements 42 may be provided on the engagement portion406 a of one or more of the extensions 406. In such embodiments, one ormore corresponding sensors is arranged on the infusion pump device 30 atlocations to detect whether or not the extensions 406 (or engagementportions 406 a) is located in a proper position, for example, within thechannel 35. In other embodiments, the sensor(s) are arranged to detectother possible positions of the extension 406 (or engagement portion 406a) within the reservoir receptacle 32.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, upon thedetection of an extensions 406 (or engagement portions 406 a) that isnot in a proper location (for example, upon detection of an engagementportion 406 a that is outside of or not sufficiently located within thechannel 35. Such predefined operations include, but are not limited toone or more of stopping or inhibiting pumping operation, allowing only alimited pumping operation, providing a warning message, or recordingdata indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) a determination that an extensions 406 (orengagement portions 406 a) is in a proper location (for example, upondetection of an engagement portion 406 a that is sufficiently locatedwithin the channel 35). Such predefined operations include, but are notlimited to one or more of allowing or continuing pumping operation,allowing a limited pumping operation, providing a predefined message, orrecording data indicating the detection.

b. Push-Fit with Oblong Ring Release

In other embodiments, the second releasable coupler includes one or moremoveable or resilient (or both) ring-shaped members on or in the housingof the infusion pump device 30 that engage one or more correspondinggrooves or stop surfaces in or on the cap (or other portion of thebase/reservoir/cap unit), when the cap (or base/reservoir/cap unit) isinstalled within the reservoir receptacle 32 of the infusion pump device30. When engaged with the groove(s) or stop surface(s), the ring-shapedmember(s) lock the cap (or other portion of the base/reservoir/cap unit)in a predefined position within the reservoir receptacle 32, and inhibitremoval of the cap (or other portion of the base/reservoir/cap unit)from the predefined position within the reservoir receptacle 32.

The ring shaped member(s) include or are connected with one or morebuttons or other interface on the outside of the housing of the infusionpump device 30. The button(s) or other interface(s) are configured to beselectively operated by a user (or medical technician or otherauthorized person) to selectively expand the ring-shaped member in atleast one dimension. The expansion of the ring-shaped member releasesthe cap (or other portion of the base/reservoir/cap unit) from thelocked state and allows the user (or medical technician or otherauthorized person) to remove the cap (or other portion of thebase/reservoir/cap unit) from the reservoir receptacle. In particularembodiments, the ring-shaped member is also expanded to install a cap(or other portion of the base/reservoir/cap unit) in the reservoirreceptacle 32 of the infusion pump device 30.

For example, in the embodiment described with reference to FIGS. 36-38,the second releasable coupler includes a ring member 502 that is made ofa material that is sufficiently rigid and strong, yet also flexible andresilient to operate as described herein. In particular embodiments, thering member 502 is made of a compliant plastic material or a siliconerubber material. The ring member 502 is configured to engage a groove ina cap 504 (or other portion of the base/reservoir/cap unit), when thecap 504 (or base/reservoir/cap unit) is installed within the reservoirreceptacle 32 of the infusion pump device 30.

An example of a cap 504 is shown in FIG. 38. As shown in FIG. 38, thecap 503 includes a groove 505 on an outer surface of the body 507 of thecap 504. In various other respects, the cap 504 may be similar to thecap 4 or other caps 404, 704 or 804 described herein.

The ring member 502 includes an annular, ring portion 503, an anchorportion 506, and a button portion 508. The ring portion 503 has an inneropening 510, and is arranged within or over the reservoir receptacle 32with axis A of the reservoir receptacle 32 extending through the inneropening 510. In particular embodiments, the ring member 502 is held by aportion of the housing of the infusion pump device 30, in the region ofthe reservoir receptacle 32, with a central point or axis of the ringportion 503 arranged at or near (or coaxial with) the axis A of thereservoir receptacle 32. The button portion 508 of the ring member 502extends through an opening or slot in housing of the infusion pumpdevice 30, at the reservoir receptacle 32. The anchor portion 506 of thering member 502 is received within a receptacle opening, slot, orindentation within the housing of the infusion pump device 30, at thereservoir receptacle 32. In the embodiment in FIGS. 36-38 the anchorportion 506 and button portion 508 are provided on mutually oppositesides of the ring portion 503 and the axis A.

When the button portion 508 of the ring member 502 is not operated, thering member 502 is in a first state (released state). In the first state(released state), the opening 510 in the ring portion 503 has a firstwidth (or diameter) D1 in a first direction, where the first directionextends along the anchor portion 506 and the button portion 508. Also inthe first state (released state), the opening 510 has a second width (ordiameter) D2 in a second direction, where the second direction extendstransverse to the first direction. In the embodiment in FIGS. 36-38, thesecond direction (of the second width D2) is approximately perpendicularto the first direction (of the first width D1). In other embodiments,the first direction is transverse, but not perpendicular, to the seconddirection.

When the button portion 508 of the ring member 502 is operated (forexample, is pushed by a finger 511 of a user, healthcare provider orother authorized person), the ring member 502 is in a second state(expanded state). In the second state (expanded state), the second width(or diameter) D2′ of the opening 510 is expanded in a second directionrelative to the second width (or diameter) D2 in the first state(released state). Also in the second state (expanded state), the firstwidth (or diameter) D1′ of the opening 510 in the ring member 502 isreduced in a first direction relative to the first width (or diameter)D1 in the first state (released state).

The ring portion 503 is configured to be at least partially receivedwithin the groove 505 in the cap 504, when the cap 504 (orbase/reservoir/cap unit) is installed in the reservoir receptacle 32 ofthe infusion pump device 30 and the ring member 502 is in the firststate (released state). When received within the groove 505, the ringportion 503 inhibits removal of the cap 504 (or base/reservoir/cap unit)from the reservoir receptacle 32 of the infusion pump device 30.However, from the state shown in FIG. 36, the button portion 508 of thering member 502 may be manually pushed to expand the second width of thering portion 503 from D2 to D2′ (the second or expanded state). Byexpanding the second width of the ring portion 503 from D2 to D2′, thering portion 503 is withdrawn from the groove 505 by a sufficient amountto allow the user to pull the cap 504 (or base/reservoir/cap unit) outof the reservoir receptacle 32.

In particular embodiments, the cap 504 includes a port for connectionwith an infusion set tubing such as, but not limited to, an infusion settubing 52 of an infusion set 50 as described above. The cap 504 alsoincludes a channel through the body portion 507 that connects to ahollow needle (not shown) similar to needle 9 described above, andprovides a fluid flow communication path from the hollow needle to theport (and to an infusion set tubing, when connected to the port). Thecap 504 also includes one or more connection features as described abovefor coupling the cap 504 to a reservoir (or to a base/reservoir unit).The cap 504 may be made of any one or more suitable materials havingsufficient rigidity and strength to operate as described herein,including, but not limited to plastic, metal, ceramic, composite orother suitable material. In one example, the cap 504 is made of a moldedplastic material, as a single, unitary, molded structure. In otherembodiments, the cap 504 may be made by other processes or in multipleparts that are assembled together (or both).

In particular embodiments, the cap 504 is provided to the user (ormedical technician or other authorized person) either separate from orconnected to a reservoir 1. If received separately, the user (or medicaltechnician or other authorized person) assembles the cap 504 with thereservoir 1 (or with the base 2 and reservoir 1 to form abase/reservoir/cap unit) as described above.

Once assembled, the base/reservoir/cap unit is inserted into thereservoir receptacle 32, along the direction of the axis AA. Inparticular embodiments, while inserting the base/reservoir/cap unit intothe reservoir receptacle 32, the user (or medical technician or otherauthorized person) pushes the button portion 508 of the ring member 502to expand the second diameter of the opening 510 from D2 to D2′. Withthe second diameter of the opening 510 expanded from D2 to D2′, the cap504 (or base/reservoir/cap unit) can be inserted into the reservoirreceptacle 32 and through the opening 510 in the ring member 502.

Once the cap 504 (or base/reservoir/cap unit) is inserted into thereservoir receptacle 32 a sufficient distance, the button portion 508may be released to allow the ring member 502 to return toward the firststate (released state), but with a portion of the body 507 of the cap504 extending through the opening 510 of the ring member 502. In thatposition, a portion of the inner surface of the opening 510 of the ringmember 502 abuts a portion of the outer surface of the body 507 of thecap 504. Then, if needed, the user (or medical technician or otherauthorized person) can make adjustments to the position of the cap 504in the direction of the axis A to align the groove 505 with the ringmember 502, to allow the ring portion 503 to be received within thegroove 505. As the groove 505 aligns with the ring portion 503 of thering member 502, the resilient return force of the ring member 502causes the ring portion 503 to move into the groove 505 and lock the cap504 (and base/reservoir/cap unit) to the reservoir receptacle 32 of theinfusion pump device 30.

Thus, in particular embodiments, the user (or medical technician orother authorized person) pushes the button portion 508 when insertingthe cap 504 (or base/reservoir/cap unit) into the reservoir receptacle32. In other embodiments, the cap 504 (or base/reservoir/cap unit) isshaped to allow the user (or medical technician or other authorizedperson) to insert the cap 504 (or base/reservoir/cap unit) into thereservoir receptacle 32 without the user also pushing the button portion508. For example, in such embodiments, the cap 504 (orbase/reservoir/cap unit) may have an outer surface that is tapered to asmaller diameter toward the bottom end of the cap 504 (orbase/reservoir/cap unit) relative to the upper end, such that thetapered outer surface engages the inner surface of the ring portion 503and expands the ring portion 503 in the second direction as the cap 504(or base/reservoir/cap unit) is moved further into the reservoirreceptacle 32 in the direction of axis A.

In particular embodiments, the resilient return force of the ring member502 and the shape of the groove 505 are configured to provide a snap-fitaction between the ring member 502 and the groove 505. In suchembodiments, the ring portion 503 and the groove 505 are configured toprovide an audible or tactile (or both) snap sound or feel (or both)that is perceptible to the user (or medical technician or otherauthorized person) as the user (or medical technician or otherauthorized person) inserts the cap 504 (or base/reservoir/cap unit) intothe reservoir receptacle 32. The snap-fit action provides the user (ormedical technician or other authorized person) with an audible ortactile (or both) indication that the cap 504 (or base/reservoir/capunit) has been sufficiently or properly received within the reservoirreceptacle 32.

The cap 504 (or base/reservoir/cap unit) may be removed from thereservoir receptacle 32 by pushing the button 508 to expand the secondwidth of the opening 510 from D2 to D2′, to withdraw the ring portion503 from the groove 505 by a sufficient amount to allow the user to pullthe cap 504 (or base/reservoir/cap unit) out of the reservoir receptacle32. With the button portion 508 pushed, the user (or medical technicianor other authorized person) pulls the cap 504 (or base/reservoir/capunit) in the direction of the axis A, out of the reservoir receptacle32. In particular embodiments, no twisting or rotational motion on thecap 504 is needed to remove the cap 504 (or base/reservoir/cap unit)from the reservoir receptacle 32.

In particular embodiments, the reservoir receptacle 32 of the infusionpump device 30 includes a spring or other bias member that imparts abias force on the cap 504 or the reservoir 1 in the direction of theaxis AA and outward from the reservoir receptacle 32, when thebase/reservoir/cap unit is installed in the reservoir receptacle 32. Insuch embodiments, the spring or bias member may be similar to the springor bias member described above with respect to the cap 404. The biasforce causes a surface (lower surface in FIG. 38) of the groove 505 topress against the a surface of the ring portion 503. In suchembodiments, the bias force helps to lock and maintain the cap 504 (andbase/reservoir/cap unit) in a predefined position within the reservoirreceptacle 32.

In the embodiment shown in FIGS. 36-38, the ring member 502 has onebutton portion 508. In other embodiments, the ring member 502 includes asecond button portion (not shown) in place of the anchor portion 506,where the second button portion extends out from the housing of theinfusion pump device in a manner similar to the button portion 508. Inparticular embodiments, the second button portion is arranged on theopposite side of the ring member 502 (and the axis A) relative to thefirst button portion 508. In such embodiments, a user (or medicaltechnician or other authorized person) may grip and squeeze the twobutton portions 508 with one hand (for example, by placing a thumb onone button portion and a first finger on the other button portion andsqueezing the button portions toward each other) to expand the ringmember to the second state (expanded state).

In the embodiment of FIGS. 36-38, the groove 505 in the cap 504 is anannular groove that extends around the entire body 507 of the cap 504.The annular shape of the groove 505 allows the cap 504 to be insertedinto the reservoir receptacle 32 in any rotational orientation (aboutthe axis A) relative to the infusion pump device 30, and still allow thering member to align with and engage the groove 505. However, othersuitable configurations of one or more stop surfaces may be employed inother embodiments. For example, other embodiments may employ one or moreindentations or recesses on the outer surface of the cap 504 body 507that form stop surfaces for engaging the ring portion 503, when the ringmember 502 is in the first state (released state) and the cap 504 (orbase/reservoir/cap unit) is received in the reservoir receptacle 32.

The embodiment shown in FIGS. 36-38 includes one ring-shaped member 502with one button portion 508. In other embodiments, two (or more)ring-shaped members are supported on or in the housing of the infusionpump device 30, in the region of the reservoir receptacle, similar tothe ring-shaped member 502 in FIGS. 36-38. In such embodiments, themultiple ring-shaped members may be arranged generally coaxially withthe reservoir receptacle 32 (with the axis A extending through the inneropening of each ring-shaped member), but arranged with their respectivebutton portions 508 at different respective locations around thecircumference of the reservoir receptacle 32. In embodiments that employmultiple ring-shaped members, the cap 504 includes a correspondingnumber (multiple) grooves 505, one for each ring-shaped member.

In the embodiment of FIGS. 36-38, the one or more ring-shaped members502 are arranged with the button portion(s) 508 positioned adjacent thereservoir receptacle 32 portion of the infusion pump device 30, andmoveable in a lateral direction (perpendicular or otherwise transverseto the axis A). In other embodiments, as represented by FIG. 39, thebutton portion 508 of each ring-shaped member 502 is engaged with alinkage structure 512. The linkage structure 512 connects to a furtherbutton portion 514 that is either located at a different (remote)location relative to the button portion 508 or is oriented in adifferent direction relative to the button portion 508, or both. In theembodiment of FIG. 39, the further button portion 514 is locatedadjacent the reservoir receptacle 32, but is oriented to move in thedirection of the axis A (upon receiving a manual pushing force in thedownward direction relative to FIG. 39). In particular embodiments, thefurther button portion 514 is also configured to be returned to anextended (un-pushed) state, when a manual pushing force is not receivedor is released, for example, by the return of the ring-shaped member 502to its first state (released state) under the natural return (resilient)force of the ring-shaped member 502.

In the embodiment of FIG. 39, the linkage structure 512 includes aramped or wedge-shaped surface on the button portion 508 that slidinglyengages a surface of the further button portion 514, when the furtherbutton portion 514 is pressed. As the further button portion 514depresses, the sliding engagement with the ramped or wedge-shapedsurface causes the button portion 508 to move toward its pressed state(and ring-shaped member 502 to expand to its second or expanded state).Accordingly, when the button portion 514 is pushed in the direction ofarrow 516, the linkage structure 512 transfers the axially directedmotion of the button portion 514 to a radially directed motion of thebutton portion 508 in the direction of arrow 518.

By releasing the button portion 514, the ring-shaped member 502 returnsto its first state (released state), which causes the further button tobe moved back to its initial (un-depressed) state. In other embodiments,the ramped or wedge-shaped surface is provided on the further buttonportion 514 at the interface of the further button portion 504 and thelinkage structure 512. In yet further embodiments, both the linkagestructure 512 and the further button portion 514 have ramped orwedge-shaped surfaces at their interface. In yet further embodiments,other suitable linkage structure for operatively connecting the furtherbutton portion 514 to the button portion 508 is employed.

Embodiments described with reference to FIGS. 36-38 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 504 or the reservoir 1 (or both) is provided withone or more detectable elements 42 described above.

Alternatively or in addition, the ring shaped member 502 is providedwith one or more detectable elements 42 described above. In embodimentsthat employ multiple ring-shaped members, a plurality of thosering-shaped members (or each of the multiple ring-shaped members) may beprovided with one or more detectable elements described above. Forexample, one or more detectable elements 42 may be provided on the ringportion 503 or the button portion 508.

In such embodiments, the infusion pump device 30 may include one or morecorresponding sensor elements 32 described above, arranged to detect thedetectable elements 42, for example, when the ring-shaped member 502 isin one or more of the first state (released state) or second state(expanded state), to detect the position of the ring-shaped memberrelative to the housing of the infusion pump device 30. In furtherembodiments, the detectable element(s) 42 and sensor element(s) arearranged such that one or more sensor elements detect one or moredetectable elements, if the ring portion 503 of the ring-shaped memberis received within the groove 505 of the cap 504.

In further examples of such embodiments, one or more additionaldetectable elements 42 are provided on the cap 504 (or other portion ofthe base/reservoir/cap unit), and one or more further sensor elements 32are arranged on the infusion pump device 30 to detect those detectableelements 42 if the cap 504 (or base/reservoir/cap unit) is properlyreceived within the reservoir receptacle 32 of the infusion pump device30 (or not properly received within the reservoir receptacle 32).Accordingly, the electronics 60 in those embodiments may be configuredto determine whether or not the cap 504 (or base/reservoir/cap unit) isproperly received within the reservoir receptacle 32 and properlyengaged with the ring-shaped member 502, based at least in part onsignals provided by sensor elements 32.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap 504 (or base/reservoir/cap unit) is notproperly received within the reservoir receptacle 32, and (2) adetermination that the ring portion 503 of the ring-shaped member is notproperly received within the groove 505 of the cap 504. Such predefinedoperations include, but are not limited to one or more of stopping orinhibiting pumping operation, allowing only a limited pumping operation,providing a warning message, and recording data indicating thedetection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap 504(or base/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) a determination that the ring portion 503 of thering-shaped member is received within the groove 505 of the cap 504.Such predefined operations include, but are not limited to one or moreof allowing or providing pumping operation, allowing a predefinedpumping operation, providing a predefined message, and recording dataindicating the detection.

c. Push-Fit with U-Shaped Release

In other embodiments, the second releasable coupler includes one or moremoveable U-shaped members on or in the housing of the infusion pumpdevice 30 that engage one or more corresponding grooves or stop surfacesin or on the cap (or other portion of the base/reservoir/cap unit), whenthe cap (or base/reservoir/cap unit) is installed within the reservoirreceptacle 32 of the infusion pump device 30. When engaged with thegroove(s) or stop surface(s), the U-shaped member(s) lock the cap (orother portion of the base/reservoir/cap unit) in a predefined positionwithin the reservoir receptacle 32, and inhibit removal of the cap (orother portion of the base/reservoir/cap unit) from the predefinedposition within the reservoir receptacle 32.

The U-shaped member(s) include or are connected with one or more buttonsor other interface on the outside of the housing of the infusion pumpdevice 30. The button(s) or other interface(s) are configured to beselectively operated by a user (or medical technician or otherauthorized person) to selectively move (slide, shift or otherwise move)the U-shaped member in at least one predefined direction. The movementof the U-shaped member in the predefined direction releases the cap (orother portion of the base/reservoir/cap unit) from the locked state andallows the user (or medical technician or other authorized person) toremove the cap (or other portion of the base/reservoir/cap unit) fromthe reservoir receptacle. In particular embodiments, the U-shaped memberis also selectively moved (slid, shifted or otherwise moved) in thepredefined direction to install a cap (or other portion of thebase/reservoir/cap unit) in the reservoir receptacle 32 of the infusionpump device 30.

For example, an embodiment of a second releasable coupler that includesa U-shaped member 602 is described with reference to FIGS. 40-42. Theembodiment in FIGS. 40-42 is configured to operate with a cap having agroove, such as, but not limited to the cap 504 with the groove 515described herein with reference to FIG. 38.

In the embodiment of FIGS. 40-42, the U-shaped member 602 that is madeof a material that is sufficiently rigid and strong to operate asdescribed herein. In particular embodiments, the U-shaped member 602 ismade of a plastic, metal, ceramic, composite material or other suitablematerial The U-shaped member 602 is configured to engage the groove 515in the cap 504 (FIG. 38), or in another portion of thebase/reservoir/cap unit, when the cap 504 (or base/reservoir/cap unit)is installed within the reservoir receptacle 32 of the infusion pumpdevice 30.

The U-shaped member 602 includes a curved portion 603, a first generallylinear portion 605 extending from one end of the curved portion 603, anda second generally linear portion 607 extending from a second end of thecurved portion 603, where the combination of the curved portion 603 andfirst and second generally linear portions 605 and 607 form a U-shape.In other embodiments, the portions 605 and 607 are not linear and,instead, have a curvature along their respective length dimensions. TheU-shaped member 602 also includes a button portion 608, connecting endsof the generally linear portions 605 and 607.

The U-shaped member 602 has an inner opening 610 located between the twogenerally linear portions 605 and 607 and between the curved portion 603and the button portion 608. The U-shaped member is arranged on or in thereservoir receptacle 32 of the infusion pump device 30 (in a mannersimilar to the manner in which the ring-shaped member 502 is supportedon or in the reservoir receptacle 32, as described above with respect toFIGS. 36-37). In particular, the U-shaped member is supported in aposition within or over the reservoir receptacle 32, with axis AA of thereservoir receptacle 32 extending through the inner opening 610.

In particular embodiments, the U-shaped member 602 is held by a portionof the housing of the infusion pump device 30, in the region of thereservoir receptacle 32, with a central point of the inner opening 610arranged at or near (or coaxial with) the axis AA of the reservoirreceptacle 32. The button portion 608 of the U-shaped member 602 extendsthrough an opening or slot in housing of the infusion pump device 30, atthe reservoir receptacle 32.

The U-shaped member 602 (including the button portion 608) is moveablebetween a first position (as shown in FIG. 40) and a second position (asshown in FIG. 41). In particular embodiments, the U-shaped member 602 isbiased toward the first position (shown in FIG. 40), for example, by aseparate spring or other bias member, or by the shape and natural springforce of the material from which the U-shaped member 602 is made. In theembodiment in FIGS. 40-42, a bias member such as, but not limited to, acoil spring 612 is interposed between the button portion 608 and thehousing of the infusion pump device 30. In other embodiments, a biasmember may be interposed between the curved portion 603 of the U-shapedmember and a portion of the housing of the infusion pump device 30 (orbetween the infusion pump device 30 and one or both of the linearportions 608 of the U-shaped member 602).

The button portion 608 has a surface 608 a located external to thehousing of the infusion pump device, in the region of the reservoirreceptacle. The surface 608 a of the button portion 608 is arranged forreceiving a manual force to overcome the force of the bias member 612and selectively move the U-shaped member 602. Thus, for example, a user(or medical technician or other authorized person) may apply a manualforce on the surface 608 a of the button portion 608, to move theU-shaped member 602 from the first position (FIG. 40) to the secondposition (FIG. 41), by pressing the surface 608 a with a finger orthumb.

When the button portion 608 is not operated, the U-shaped member 602 isin the first position. When the U-shaped member 602 is in the firstposition while a cap 504 (or base/reservoir/cap unit) is properlyreceived in the reservoir receptacle 32, the curved portion 603 of theU-shaped member 602 engages the groove 505 of the cap 504 to inhibitmovement of the cap 504 (and base/reservoir/cap unit) relative to thereservoir receptacle 32, in the direction of the axis AA. In particularembodiments, the curved portion 603 is configured to be at leastpartially received within the groove 505 in the cap 504, when the cap504 (or base/reservoir/cap unit) is installed in the reservoirreceptacle 32 of the infusion pump device 30 and the U-shaped member 602is in the first position (FIG. 40). When received within the groove 505,the curved portion 603 inhibits removal of the cap 504 (orbase/reservoir/cap unit) from the reservoir receptacle 32 of theinfusion pump device 30.

However, from the state shown in FIG. 39, the button portion 608 of theU-shaped member 602 may be manually pushed to move the U-shaped member602 from the first position toward the second position. As the U-shapedmember 602 moves toward the second position, the curved portion 603 iswithdrawn from the groove 505 by a sufficient amount to allow the userto pull the cap 504 (or base/reservoir/cap unit) out of the reservoirreceptacle 32.

As described above, the base/reservoir/cap unit is inserted into thereservoir receptacle 32, along the direction of the axis AA. Inparticular embodiments, while inserting the base/reservoir/cap unit intothe reservoir receptacle 32, the user (or medical technician or otherauthorized person) pushes the button portion 608 of the U-shaped member602 to move the U-shaped member 602 toward the second position (FIG.41). When the U-shaped member 602 is moved sufficiently toward thesecond position, the cap 504 (or base/reservoir/cap unit) can beinserted into the reservoir receptacle 32 and through the opening 610 inthe U-shaped member 602.

Once the cap 504 (or base/reservoir/cap unit) is inserted into thereservoir receptacle 32 a sufficient distance, the button portion 608may be released to allow the U-shaped member 602 to return toward thefirst state (released state), for example, via a return force from thebias member 612, but with a portion of the body 507 of the cap 504extending through the opening 610 of the U-shaped member 602. In thatposition, a portion of the inner surface of the curved portion 603 inthe opening 610 of the U-shaped member 602 abuts and presses against aportion of the outer surface of the body 507 of the cap 504. Then, ifneeded, the user (or medical technician or other authorized person) canmake adjustments to the position of the cap 504 in the direction of theaxis A to align the groove 505 with the curved portion 603 of theU-shaped member 602, to allow the curved portion 603 to be receivedwithin the groove 505. As the groove 505 aligns with the curved portion603 of the U-shaped member 602, the resilient return force of the curvedportion 603 causes the curved portion 603 to move into the groove 505and lock the cap 504 (and base/reservoir/cap unit) to the reservoirreceptacle 32 of the infusion pump device 30.

Thus, in particular embodiments, the user (or medical technician orother authorized person) pushes the button portion 608 when insertingthe cap 504 (or base/reservoir/cap unit) into the reservoir receptacle32. In other embodiments, the cap 604 (or base/reservoir/cap unit) isshaped to allow the user (or medical technician or other authorizedperson) to insert the cap 504 (or base/reservoir/cap unit) into thereservoir receptacle 32 without the user also pushing the button portion608. For example, in such embodiments, the cap 504 (orbase/reservoir/cap unit) may have an outer surface that is tapered to asmaller diameter toward the bottom end of the cap 504 (orbase/reservoir/cap unit) relative to the upper end, such that thetapered outer surface engages the inner surface of the curved portion503 and pushes the U-shaped member 602 toward the second position as thecap 504 (or base/reservoir/cap unit) is moved further into the reservoirreceptacle 32 in the direction of axis A.

In particular embodiments, the return force of the bias member 612 andthe shapes of the curved portion 603 and the groove 505 are configuredto provide a snap-fit action between the U-shaped member 602 and thegroove 505. In such embodiments, the curved portion 603 and the groove505 are configured to provide an audible or tactile (or both) snap soundor feel (or both) that is perceptible to the user (or medical technicianor other authorized person) as the user (or medical technician or otherauthorized person) inserts the cap 504 (or base/reservoir/cap unit) intothe reservoir receptacle 32. The snap-fit action provides the user (ormedical technician or other authorized person) with an audible ortactile (or both) indication that the cap 504 (or base/reservoir/capunit) has been sufficiently or properly received within the reservoirreceptacle 32.

The cap 504 (or base/reservoir/cap unit) may be removed from thereservoir receptacle 32 by pushing the button portion 608 to move theU-shaped member 602 toward the second position, to withdraw the curvedportion 503 from the groove 505 by a sufficient amount to allow the userto pull the cap 504 (or base/reservoir/cap unit) out of the reservoirreceptacle 32. With the button portion 608 pushed, the user (or medicaltechnician or other authorized person) pulls the cap 504 (orbase/reservoir/cap unit) in the direction of the axis A, out of thereservoir receptacle 32. In particular embodiments, no twisting orrotational motion on the cap 504 is needed to remove the cap 504 (orbase/reservoir/cap unit) from the reservoir receptacle 32.

In particular embodiments, the reservoir receptacle 32 of the infusionpump device 30 includes a spring or other bias member that imparts abias force on the cap 504 or the reservoir 1 in the direction of theaxis A and outward from the reservoir receptacle 32, when thebase/reservoir/cap unit is installed in the reservoir receptacle 32. Insuch embodiments, the spring or bias member may be similar to the springor bias member described above with respect to the cap 404. The biasforce causes a surface (lower surface in FIG. 38) of the groove 505 topress against the a surface of the curved portion 603. In suchembodiments, the bias force helps to lock and maintain the cap 504 (andbase/reservoir/cap unit) in a predefined position within the reservoirreceptacle 32.

The embodiment shown in FIGS. 40-41 includes one U-shaped member 602with one button portion 608. In other embodiments, two (or more)U-shaped members are supported on or in the housing of the infusion pumpdevice 30, in the region of the reservoir receptacle, similar to theU-shaped member 602 in FIGS. 40-41. In such embodiments, the multipleU-shaped members may be arranged generally coaxially with the reservoirreceptacle 32 (with the axis A extending through the inner opening 610of each U-shaped member), but arranged with their respective buttonportions 608 at different respective locations around the circumferenceof the reservoir receptacle 32.

For example, in the embodiment represented by FIG. 42, two U-shapedmembers 602 and 602′ are arranged over a reservoir receptacle 32 of aninfusion pump device 30, with the U-shaped member 602 arranged adjacent(above) the U-shaped member 602′ or spaced apart from the U-shapedmember 602′ in the direction of the axis A. The button portion 608 ofthe U-shaped member 602 is arranged on the opposite side of the axis A(180 degrees apart) relative to the button portion 608 a of the U-shapedmember 608. In that configuration, a user (or medical technician orother authorized person) may operate both U-shaped memberssimultaneously (to move both U-shaped members from their respectivefirst positions to their respective second positions), with one hand, byplacing a thumb on one of the button portions and a first finger on theother button portion and squeezing the thumb and finger toward eachother. In other embodiments, more than two U-shaped members (and buttonportions) may be employed, such that more than one hand would be used tooperate (move) all of the U-shaped members, simultaneously, to unlockthe cap 504.

In embodiments that employ two or more U-shaped members 602, 602′, etc.,the cap 504 includes a corresponding number (two or more) grooves 505 incap 504. In such embodiments, each U-shaped member 602, 602′, etc., isarranged to align with and be received in a different respective one ofthe grooves 505, when the cap 504 (or base/reservoir/cap unit) isproperly installed in the reservoir receptacle 32, as described above.In that state, the two or more U-shaped members 602, 602′, etc. inhibitremoval of the cap 503 (or base/reservoir/cap unit) from the reservoirreceptacle 32. From that state, the button portions 608, 608′, etc. ofeach of the U-shaped members 602, 602′, etc., may be operatedsimultaneously (manually pushed at the same time), to move the U-shapedmembers 602, 602′, etc. toward their respective second positions. As aresult, the curved portion 603 of each U-shaped member 602, 602′, etc.withdraws from its corresponding groove 505 by a sufficient amount toallow the user to pull the cap 504 (or base/reservoir/cap unit) out ofthe reservoir receptacle 32.

In the embodiment of FIGS. 40-42, the one or more U-shaped members 602,602′, etc. are arranged with the button portion(s) 608 positionedadjacent the reservoir receptacle 32 portion of the infusion pump device30, and moveable in a lateral direction (perpendicular or otherwisetransverse to the axis A). In other embodiments, similar to thatrepresented by FIG. 39, the button portion 608 of each U-shaped member602 is engaged with a linkage structure 512. The linkage structure 512connects to a further button portion 514 that is either located at adifferent (remote) location relative to the button portion 608 or isoriented in a different direction relative to the button portion 608, orboth. In the embodiment of FIG. 39, the further button portion 514 islocated adjacent the reservoir receptacle 32, but is oriented to move inthe direction of the axis A (upon receiving a manual pushing force inthe downward direction relative to FIG. 39). In particular embodiments,the further button portion 514 is also configured to be returned to anextended (un-pushed) state, when a manual pushing force is not receivedor is released, for example, by the return of the U-shaped member 602 toits first state (released state) under the return bias force of the biasmember 612.

Embodiments described with reference to FIGS. 40-42 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 504 or the reservoir 1 (or both) is provided withone or more detectable elements 42 described above.

In particular embodiments, the U-shaped member 602 is provided with oneor more detectable elements 42 described above. In embodiments thatemploy multiple U-shaped members 602, 602′, etc., a plurality of thoseU-shaped members (or each of the multiple U-shaped members) may beprovided with one or more detectable elements described above. Forexample, one or more detectable elements 42 may be provided on thecurved portion 603, the button portion 608 or any one (or both) of thelinear portions 605 of the U-shaped member 602, 602′, etc.

In such embodiments, the infusion pump device 30 may include one or morecorresponding sensor elements 32 described above, arranged to detect thedetectable elements 42, for example, when the U-shaped member (602,602′, etc.) is in one or more of the first position, the second positionor other positions between the first and second position, to detect theposition of the U-shaped member relative to the housing of the infusionpump device 30. In further embodiments, the detectable element(s) 42 andsensor element(s) are arranged such that one or more sensor elementsdetect one or more detectable elements, if the curved portion 603 of theU-shaped member is received within the groove 505 of the cap 504.

In further examples of such embodiments, one or more additionaldetectable elements 42 are provided on the cap 504 (or other portion ofthe base/reservoir/cap unit), and one or more further sensor elements 32are arranged on the infusion pump device 30 to detect those detectableelements 42 if the cap 504 (or base/reservoir/cap unit) is properlyreceived within the reservoir receptacle 32 of the infusion pump device30 (or not properly received within the reservoir receptacle 32).Accordingly, the electronics 60 in those embodiments may be configuredto determine whether or not the cap 504 (or base/reservoir/cap unit) isproperly received within the reservoir receptacle 32 and properlyengaged with the U-shaped member (602, 602′, etc.), based at least inpart on signals provided by sensor elements 32.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap 504 (or base/reservoir/cap unit) is notproperly received within the reservoir receptacle 32, and (2) adetermination that the curved portion 603 of the U-shaped member is notproperly received within the groove 505 of the cap 504. Such predefinedoperations include, but are not limited to one or more of stopping orinhibiting pumping operation, allowing only a limited pumping operation,providing a warning message, and recording data indicating thedetection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap 504(or base/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) a determination that the curved portion 603 ofthe U-shaped member is received within the groove 505 of the cap 504.Such predefined operations include, but are not limited to one or moreof allowing or providing pumping operation, allowing a predefinedpumping operation, providing a predefined message, and recording dataindicating the detection.

d. Twist-Lock with Push Button Release

In other embodiments as described with reference to FIGS. 43-47, thesecond releasable coupler includes one or more resilient extensions 700on a cap 704. The extension(s) 700 are configured to engage and bedeflected inward by the inner surface 32 c of the reservoir receptacle32, as the cap 704 (or base/reservoir/cap unit) is moved into thereservoir receptacle 32, until the resilient extension(s) engage one ormore grooves, indentations or other stop surfaces 32 d in the reservoirreceptacle 32. When engaged with the stop surface(s) 32 d, the resilientextension(s) retain and lock the cap 704 (or base/reservoir/cap unit)within the reservoir receptacle.

In particular embodiments, the one or more resilient extensions 700 areflexible to selectively disengage the stop surfaces sufficiently toallow removal of the cap (or base/reservoir/cap unit) from the reservoirreceptacle 32. For example, in FIGS. 43-47, the infusion pump device 30includes one or more (two in FIGS. 36-40) button members 708 that areconfigured to be manually pressed by a user (or medical technician orother authorized person) to selectively move the resilient extension(s)700 an amount to sufficiently disengage the stop surfaces 32 d. In otherexamples, the one or more resilient extensions 700 may be configured toflex to sufficiently disengage the stop surfaces 32 d when a manualforce (rotary or linear, or both) greater than a predefined amount isapplied to the cap 704 (or other portion of the base/reservoir/cap unit)by a user (or medical technician or other authorized person).

Each extension 700 has an engagement portion 702 that is configured toengage a respective sloped or ramped section 32 c on the inner surface32 b of the reservoir receptacle 32, when the cap 700 (orbase/reservoir/cap unit) is initially moved into the reservoirreceptacle 32. In FIGS. 43-47, the cap 704 has two extensions 700, andthe inner surface 32 b of the reservoir receptacle 32 has acorresponding number of (two) ramped surface section 32 c, one for eachextension 700. Each ramped surface section 32 c has a surface thatslopes inward toward the axis A, from a first circumferential location32 c′ to a second circumferential location 32 c″ along the rampedsection 32 c. A stop surface 32 d is located at the secondcircumferential location 32 c″ of each ramped section 32 c. In theembodiment of FIGS. 43-47, each stop surface 32 d includes anindentation in the inner surface 32 b of the reservoir receptacle,located at one end of each ramped section 32 c.

The ramped sections 32 c are configured to align with the engagementportions 702 of the extensions 700 on the cap 704, when the cap 704 (orbase/reservoir/cap unit) is initially received within the reservoirreceptacle. The cap 704 (or base/reservoir/cap unit) is configured to berotated in a first direction (e.g., the direction of arrow 706 in FIGS.43 and 44) around the axis A, once the cap 704 (or base/reservoir/capunit) is initially received within the reservoir receptacle. The cap 704includes an extended grip portion 705 that provides a surface forallowing a user (or medical technician or other authorized person) togrip the cap 704 and apply a manual force in the rotational direction ofarrow 706. As the cap 704 (or base/reservoir/cap unit) is rotated, theengagement portions 702 of the extensions 700 on the cap 704 ride alongthe surfaces of the ramp sections 32 c. The inward slope of the rampsections causes the extensions 700 to flex inward (toward the axis A) asthe cap 704 (or base/reservoir/cap unit) is rotated in the direction ofarrow 706.

The extensions 700 are configured to continue to ride along the surfacesof the ramp sections 32 c and flex inward until the extensions 700 alignwith and engage the stop surfaces 32 d. When engaged with the stopsurfaces 32 d, the resilient extensions 700 retain and lock the cap (orbase/reservoir/cap unit) within the reservoir receptacle. In theembodiment of FIGS. 43-47, the stop surfaces 32 d include indentationsthat allow the resilient extensions 700 to flex outward slightly and theengagement portions 702 to extend at least partially into theindentations, upon alignment of the engagement portions 702 with theindentations (as shown in FIG. 44).

In particular embodiments, the extensions 700, engagement portions 702and the stop surfaces 32 d (or both) are made of materials that havesufficient rigidity to secure the cap 704 to the infusion pump device 30when the engagement portions 702 are in the indentations of the stopsurfaces 32 d, but sufficiently flexible and resilient to allow theengagement portion 702 to be snapped into indentations of the stopsurfaces 32 d. In such embodiments, as the cap 704 is rotated, theengagement portions 702 ride along the ramp portion 32 c as theextensions 700 flex, until the engagement portions 702 align with andsnap into the indentations of the stop surfaces 32 d. In particularembodiments, the cap 704 is configured to provide a snap sound orsnap-like feel that is perceptible to a person installing the cap 704(or base/reservoir/cap unit) in the reservoir receptacle 32.

When engaged with the indentations of the stop surfaces 32 d, theresilient extensions 700 inhibit removal of the cap 704 (orbase/reservoir/cap unit) from the reservoir receptacle 32 of theinfusion pump device 30. However, from the state shown in FIG. 43, thetwo extensions 700 may be manually flexed inward (toward the axis A) byoperating a pair of button members 708 (one shown in view in FIG. 43,the other being out of view, on the opposite side of the reservoirreceptacle 32, relative to the axis A). The button members 708 areoperated to flex the extensions 700 inward, to withdraw the extensions700 from the indentations of the stop surfaces 32 d by a sufficientamount to allow the user to remove the cap 704 (or base/reservoir/capunit) from the reservoir receptacle 32. In particular embodiments, thereservoir receptacle 32 and cap 704 are configured to allow the cap 704(or base/reservoir/cap unit) to be pulled outward in the lineardirection of the axis A, without requiring rotating or twisting, toremove the cap 704 (or base/reservoir/cap unit) from the reservoirreceptacle 32, when the button members 708 are operated to withdraw theextensions 700 from the indentations by a sufficient amount.

In the embodiment of FIGS. 43-47, each button member 708 includes a bodythat is supported in an indentation in the housing of the infusion pumpdevice 30, adjacent the open port of the reservoir receptacle. The bodyof each button member 708 has a surface 708 a that is exposed fromoutside of the housing of the infusion pump device 30 in a position atwhich it may be pressed by a finger or thumb of a user (or medicaltechnician or other authorized person), to operate the button member708. The body of each button member 708 also includes a linkage portion708 b that extends through a passage or opening in the housing of theinfusion pump device 30 and has a surface 708 c located adjacent orpartially within an indentations of one of the stop surfaces 32 d, onthe inside of the reservoir receptacle 32. In particular embodiments,each button member 708 includes spring or other bias member 714 arrangedto bias the button member 708 outward in the radial direction relativeto the axis A. Each button member 708 is configured to be manuallypressed on its surface 708 a, to move the linkage portion 708 b inwardin the radial direction relative to the axis A. If an engagement portion702 of an extension 700 is in the indentation of the stop surface 32 dassociated with the button member 708, then the surface 708 c of thebutton member 708 forces the extension arm 700 inward, as the buttonmember 708 is pushed. By pushing the button member 708 a sufficientdistance, the extension 700 is flexed inward an amount to withdraw theengagement portion 702 of the extension 700 out of the indentation ofthe stop surface 32 d a sufficient amount to allow the cap 704 (orbase/reservoir/cap unit) to be removed from the reservoir receptacle 32,as described above.

In particular embodiments, the cap 704 includes one or more alignmentfeatures 710 that align with one or more corresponding or matingfeatures 712 located on the infusion pump device 30, in the region ofthe port of the reservoir receptacle 32, to align the cap 704 in one ormore predefined rotated positions relative to the axis A, when the cap704 (or base/reservoir/cap unit) is initially received in the reservoirreceptacle 32. The one or more predefined positions are locations atwhich the engagement portions 702 of the extensions 700 engage the rampportion 32 c, at or near the first location 32 c′, when the cap 704 (orbase/reservoir/cap unit) is initially received by the reservoirreceptacle 32.

Accordingly, the cap 704 (or base/reservoir/cap unit) may be installedin the infusion pump device 30 by inserting cap 704 (orbase/reservoir/cap unit) through the open port of the reservoirreceptacle and manually aligning the alignment features 710 and 712, asshown in FIG. 43. In that state, the extensions 700 engage the slopingsurface of the ramp portion 32 c, at or near the first location 32 c′ ofthe ramp portions 32 c. From that state, the cap 704 may be manuallyrotated in the direction of the arrow 706 to cause the engagementportions 702 of the extensions 700 to ride along the sloped surfaces ofthe ramp sections 32 c until the engagement portions 702 align with theindentations of the stop surfaces 32 d. At that state, the engagementportions 702 are received (at least partially) within the indentationsof the stop surfaces 32 d and the extensions 700 flex outward to retainand lock the cap 704 (and base/reservoir/cap unit) in an operatingposition within the reservoir receptacle 32.

As discussed above, the cap 704 (and base/reservoir/cap unit) may beremoved from the reservoir receptacle 32 by manually pressing all of thebutton members 708 at the same time, to flex the extensions 700 inwardto withdraw the engagement portions 702 from the indentations sufficientto allow the cap 704 (and base/reservoir/cap unit) to be manually pulledoutward (along the direction of the axis A) from the reservoirreceptacle 32.

In the embodiment of FIGS. 43-47, the cap 704 is configured to becoupled to a reservoir (or base and reservoir) as described above, foroperation with the infusion pump device 30 in manner similar to theoperation of the cap 4 and reservoir 1 as described above. The cap 704includes a port 707 for connection with an infusion set tubing such as,but not limited to, an infusion set tubing 52 of an infusion set 50 asdescribed above. The cap 704 also includes a body portion through whicha channel 709 extends. The channel 709 connects to a hollow needle (notshown) similar to needle 9 described above, and provides a fluid flowcommunication path from the hollow needle to the port 707 (and to aninfusion set tubing, when connected to the port 707). The cap 704 alsoincludes one or more connection features (e.g. of the first releasablecoupler as described above) for coupling the cap 704 to a reservoir (orto a base/reservoir unit).

The cap 704 may be made of any one or more suitable materials havingsufficient rigidity and strength to operate as described herein,including, but not limited to plastic, metal, ceramic, composite orother suitable material. In one example, the cap 704 (including theresilient extensions 700, grip 705, port 707 and the cap body) is madeof a molded plastic material, as a single, unitary, molded structure. Inother embodiments, the cap 704 may be made by other processes or inmultiple parts that are assembled together (or both).

In the embodiment of FIGS. 43-47, the alignment features 710 areoutwardly extending tabs on the cap 704, while the alignment features712 are inward extending slots in the housing of the infusion pumpdevice 30, at the open port of the reservoir receptacle, where the slotsare shaped to receive the tabs, when aligned. In other embodiments, themating alignment features 710 and 712 have other suitable configurationsthat allow the cap 704 to be received by the reservoir receptacle 32 inone or more predefined positions, where such other configurationsinclude one or more other tabs and slots, keyed surfaces, surface shapesor other shape features.

In the embodiment of FIGS. 43-47, each stop surface 32 a includes anindentation shaped to align with and receive at least a portion of theengagement portion 702 of an extension 700. In other embodiments, thestop surface 32 a includes one or more other features provided in thereservoir receptacle, such as, but not limited to, an extension,protrusion, groove, or other structural feature provided on an innersurface 32 b of the reservoir receptacle 32.

The embodiment of FIGS. 43-47 includes two extensions 700, two rampportions 32 c, two stop surfaces 32 d and two button members 708. Otherembodiments employ only one of each of those features. Yet otherembodiments employ more than two of each of those features.

In the embodiment of FIGS. 43-47, the two extensions 700 are located onopposite sides of the cap 704 and the axis A relative to each other and,similarly, the two button members 708 are located on opposite sides ofthe cap and the axis A relative to each other. In addition, the two rampportions 32 c and two stop surfaces 32 d are located, relative to eachother, on opposite sides of the reservoir receptacle and axis A. Thatconfiguration allows the two button members 708 to be operatedsimultaneously, with one hand, for example, by pressing one buttonmember 708 with a thumb and the other button member 708 with the firstfinger of the same hand. In other embodiments, the extensions, buttonmembers, ramp portions and stop surfaces are located in other suitablelocations.

Embodiments described with reference to FIGS. 43-47 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 704 or the reservoir 1 (or both) is provided withone or more detectable elements 42 described above.

In particular embodiments, one or more (or all) of the extensions 700 ofthe cap is provided with one or more detectable elements 42 describedabove. In such embodiments, the infusion pump device 30 may include oneor more corresponding sensor elements 32 described above, arranged todetect the detectable elements 42, for example, when extensions 700 areengaged with the ramp portion 32 c, or when the extensions are engagedwith the stop surface 32 d, or when the extensions are flexed (or anycombination thereof). In further embodiments, one or more (or all) ofthe tabs or other alignment features 710 is provided with one or moredetectable elements 42 described above. In such embodiments, theinfusion pump device 30 may include one or more corresponding sensorelements 32 described above, arranged to detect the detectable elements42, for example, when alignment features 710 on the cap 704 are properlyaligned with or mated with corresponding alignment features on theinfusion pump device 30.

In further examples of such embodiments, one or more additionaldetectable elements 42 are provided on the cap 704 (or other portion ofthe base/reservoir/cap unit), and one or more further sensor elements 32are arranged on the infusion pump device 30 to detect those detectableelements 42 if the cap 704 (or base/reservoir/cap unit) is properlyreceived within the reservoir receptacle 32 of the infusion pump device30 (or not properly received within the reservoir receptacle 32).Accordingly, the electronics 60 in those embodiments may be configuredto determine whether or not the cap 704 (or base/reservoir/cap unit) isproperly received within the reservoir receptacle 32, or whether or notthe extensions 700 are properly engaged with the stop surfaces 32 d, orboth.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap 704 (or base/reservoir/cap unit) is notproperly received within the reservoir receptacle 32, and (2) adetermination that the extensions 700 are not properly received withinthe indentations of the stop surfaces 32 c. Such predefined operationsinclude, but are not limited to one or more of stopping or inhibitingpumping operation, allowing only a limited pumping operation, providinga warning message, and recording data indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap 704(or base/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) a determination that the extensions 700 areproperly received within the indentations of the stop surfaces 32 c.Such predefined operations include, but are not limited to one or moreof allowing or providing pumping operation, allowing a predefinedpumping operation, providing a predefined message, and recording dataindicating the detection.

e. Push-in Lock with Pinch Release

In other embodiments as described with reference to FIGS. 48-51, thesecond releasable coupler includes one or more features 800 on a skirtportion 802 of a cap 804, that engage and mate with one or more features39 on the housing of the infusion pump device 30, in the region of theopen port of the reservoir receptacle 32. In the embodiment of FIGS.48-51, the feature(s) 800 include a pair of open slots in the skirtportion 802 of the cap 804, and the feature(s) 39 include an outwardextending annular lip around the open port of the reservoir receptacle32.

The cap 804 includes a body portion 803 configured to couple to areservoir 1 (for example, with a first releasable coupler as describedabove, or other suitable coupling structure), and to fit at leastpartially within the reservoir receptacle 32, when the cap 804 (orbase/reservoir/cap unit) is installed within the reservoir receptacle 32(for example, as described above with respect to caps 4, 204, 404, 504,604 and 704, or in another suitable manner). The skirt portion 802 ofthe cap 804 extends over the outside of a body portion 803 of the cap804 and has one end (the end of the skirt portion 802 that is adjacentto the reservoir-coupling end of the body portion 803 of the cap 804)that is open to a space 806 between the interior surface 802 a of theskirt portion 802 and the exterior surface 803 a of the body portion803.

When the cap 804 (or base/reservoir/cap unit) is installed in thereservoir receptacle 32, the body portion 803 of the cap 804 fits atleast partially within the reservoir receptacle 32 (for example, asdescribed above with respect to caps 4, 204, 404, 504, 604 and 704, orin another suitable manner) while the skirt portion 802 extends at leastpartially over the outside of the open port of the reservoir receptacle32. In particular, when the cap 804 (or base/reservoir/cap unit) isinstalled in the reservoir receptacle 32, an end portion of the port ofthe reservoir receptacle 32 fits at least partially into the space 806between the skirt portion 802 and the body portion 803 of the cap 804.

In the embodiment in FIGS. 48-51, the skirt portion 802 of the cap 804has an oblong or oval-shape at its open end, and is wider in onedimension (D₁) than in a second dimension (D₂). In particularembodiments, the width of the interior surface of the skirt in thesecond dimension D₂ is smaller than the diameter of the open port end ofthe reservoir receptacle 32, while the width of the interior surface ofthe skirt in the first dimension D₁ is larger than the diameter of theopen port end of the reservoir receptacle 32. In such embodiments, theskirt portion 802 is configured of a material or structure (or both)that is sufficiently resilient and flexible to expand in the seconddimension (D₂) when a sufficient squeezing force is applied to the skirtin the direction of the first dimension (D₁). Furthermore, in suchembodiments, the skirt portion 802 is sufficiently resilient to returnto the un-squeezed configuration, when the squeezing force is released.

The shape and size of the skirt portion 802 and of the engagementfeatures (slots) 800 are configured to allow the skirt portion 802 tofit over the end of the port of the reservoir receptacle 32 when theskirt portion 802 is expanded in the second dimension D₂ (for example,by manually squeezing the skirt portion 802 in the first dimension D₁).In the expanded (squeezed) state, the skirt portion 802 of the cap 804may be fitted over the end portion of the port of the reservoirreceptacle 32 as the cap 804 (or base/reservoir/cap unit) is moved intothe reservoir receptacle 32.

Once the cap 804 (or base/reservoir/cap unit) is sufficiently insertedinto the reservoir receptacle 32, the skirt portion 802 may be returnedto its unexpanded state (for example, by releasing the manual squeezingforce on the skirt portion 802). As the skirt portion 802 returns to theunexpanded, the engagement features (slots) 800 on the skirt portion 802engage and receive the engagement feature (lip) 39 around the port ofthe reservoir receptacle 32. In that state, the cap 804 (orbase/reservoir/cap unit) is retained and locked in the reservoirreceptacle 32, in an operating position.

From that state, the cap 804 (or base/reservoir/cap unit) may be removedfrom the reservoir receptacle 32, by applying a squeezing force on theskirt portion 802 in the first dimension D₁ to cause the skirt portion802 to expand in the second dimension D₂ to withdraw the engagementfeatures (slots) 800 from the engagement feature (lip) 39 by asufficient amount to unlock the cap 804 and allow the cap 804 (orbase/reservoir/cap unit) to be manually pulled out of the reservoirreceptacle 32.

In the embodiment of FIGS. 48-51, the cap 804 is configured to becoupled to a reservoir (or base and reservoir) as described above, foroperation with the infusion pump device 30 in manner similar to theoperation of the cap 4 and reservoir 1 as described above. The cap 804includes a port 807 for connection with an infusion set tubing such as,but not limited to, an infusion set tubing 52 of an infusion set 50 asdescribed above. The body portion 803 of the cap 804 includes a channel809 that connects to a hollow needle (not shown) similar to needle 9described above, and provides a fluid flow communication path from thehollow needle to the port 807 (and to an infusion set tubing, whenconnected to the port 807).

The cap 804 may be made of any one or more suitable materials havingsufficient rigidity and strength to operate as described herein,including, but not limited to plastic, metal, ceramic, composite orother suitable material. In one example, the cap 804 (including theresilient skirt portion 802) is made of a molded plastic material, as asingle, unitary, molded structure. In other embodiments, the cap 804 maybe made by other processes or in multiple parts that are assembledtogether (or both).

In the embodiment of FIGS. 48-51, the skirt portion 802 of the cap 804has an outer surface that includes one or more friction features 808.The friction features 808 are provided to identify a location on theskirt portion 802 to apply a manual squeezing force, as described above.In addition, the friction features 808 are configured to inhibit afinger or thumb from slipping off of the skirt portion 802, whenapplying a manual squeezing force. In the embodiment in FIGS. 48-51,first and second friction features are provided on the skirt portion802, at locations along the first dimension D₁. In the embodiment inFIGS. 48-51, each friction feature includes a set of raised ribs. Inother embodiments, other suitable friction features may be used forenhancing friction between a finger or thumb and the skirt portion 802,including, but not limited to, grooves, protrusions, one or more pads ofmaterial having a higher friction coefficient than the material of theskirt portion 802, or the like.

The embodiment of FIGS. 48-51 includes two engagement features (slots)800 on the skirt portion 802. Other embodiments employ only oneengagement feature (slot) 800, while yet other embodiments include morethan two engagement features (slots) 800 on the skirt portion 802. Also,while the embodiment of FIGS. 48-51 includes one engagement feature(lip) 39 on the infusion pump device 30, other embodiments employ morethan one engagement features (lip, protrusion or the like) 39 on theinfusion pump device 30.

In the embodiment of FIGS. 48-51, the feature(s) 800 include a pair ofopen slots in the skirt portion 802 of the cap 804. In otherembodiments, the engagement features 800 include other suitablestructure for engaging the engaging features 39 on the infusion pumpdevice 30, including, but not limited to one or more grooves,indentations, apertures or the like. In other embodiments, thefeature(s) 800 include a protruding feature, such as, but not limited toone or more ribs or other protrusions, while the engagement features 39include mating slots, grooves, indentations, apertures or the like.

In the embodiment of FIGS. 48-51, the feature(s) 39 include an annular,outward-extending lip around the port of the reservoir receptacle 32. Inother embodiments, the engagement feature 39 includes other suitablestructure for engaging mating engaging features 800 on the cap 804,including, but not limited to one or more protrusions, slots, grooves,indentations, apertures or the like.

Embodiments described with reference to FIGS. 48-51 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 804 or the reservoir 1 (or both) is provided withone or more detectable elements 42 described above.

In particular embodiments, the skirt portion 802 of the cap 804 isprovided with one or more detectable elements 42 described above. Insuch embodiments, the infusion pump device 30 may include one or morecorresponding sensor elements 32 described above, arranged to detect thedetectable elements 42, for example, when engagement features 800 areengaged with the engagement features 39, or when the skirt portion 802is extended over the port end of the reservoir receptacle 32, or whenthe port end of the reservoir receptacle 32 is received within the space806 (or any combination thereof).

In further examples of such embodiments, one or more additionaldetectable elements 42 are provided on the cap 804 (or other portion ofthe base/reservoir/cap unit), and one or more further sensor elements 32are arranged on the infusion pump device 30 to detect those detectableelements 42 if the cap 804 (or base/reservoir/cap unit) is properlyreceived within the reservoir receptacle 32 of the infusion pump device30 (or not properly received within the reservoir receptacle 32).Accordingly, the electronics 60 in those embodiments may be configuredto determine whether or not the cap 804 (or base/reservoir/cap unit) isproperly received within the reservoir receptacle 32, engagementfeatures 800 are engaged with the engagement features 39, or whether ornot the skirt portion 802 is extended over the port end of the reservoirreceptacle 32.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap 804 (or base/reservoir/cap unit) is notproperly received within the reservoir receptacle 32, (2) adetermination that the engagement features 800 are not sufficientlyengaged with the engagement features 39, and (3) a determination thatthe skirt portion 802 is not sufficiently extended over the port end ofthe reservoir receptacle 32. Such predefined operations include, but arenot limited to one or more of stopping or inhibiting pumping operation,allowing only a limited pumping operation, providing a warning message,and recording data indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap 804(or base/reservoir/cap unit) is properly received within the reservoirreceptacle 32, (2) a determination that the engagement features 800 areengaged with the engagement features 39, and (3) a determination thatthe skirt portion 802 is extended over the port end of the reservoirreceptacle 32. Such predefined operations include, but are not limitedto one or more of allowing or providing pumping operation, allowing apredefined pumping operation, providing a predefined message, andrecording data indicating the detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

f. Pinch to Connect and Release

In further embodiments as described with reference to FIGS. 52-54, thesecond releasable coupler includes a flexible arm structure thatincludes one or more flexible arms 900 formed on or attached to the cap904 a. Each flexible arm 900 includes a tab 902 configured to engage acorresponding indentation, opening, groove, stop surface or otherengagement feature on the infusion pump device 30, when the cap 904 a(or base/reservoir/cap unit) is installed in the reservoir receptacle ofthe infusion pump device 30. FIG. 52 shows a top-down view of a cap 904a that includes two flexible arms 900, provided on opposite sides ofhousing 905 of the cap 904 a (on opposite sides of the axis A) relativeto each other. That arrangement allows the two flexible arms 900 to bemanually squeezed toward each other with one hand, to release the cap(or base/reservoir/cap unit) as described below. However, in otherembodiments, one or more flexible arms 900 may be arranged in anysuitable location on the housing 905 of the cap 904 a.

Each flexible arm 900 has a free end portion 900 a and extends (at asecond end portion 900 b) from the rest of the housing 905 in acantilever manner. In the embodiment of FIGS. 52-54, the housing 905 ofthe cap 904 a has a shape or indentation adjacent each flexible arm 900to provide a gap 903 between the flexible arm 900 and another portion ofthe housing 905 of the cap. In such embodiments, each flexible arm 900has an outer surface 906 that follows the contour of the outer surfaceof adjacent portions of the housing 905, when the flexible arm 900 is inthe un-flexed state (as shown in FIG. 52) In other embodiments, eachflexible arm 900 extends outward from the housing 905 of the cap 904 a,to form a gap 903 between the flexible arm and the housing 905. Eachflexible arm 900 is sufficiently flexible to bend inward, into the gap903, toward a central portion of the cap 904 a, when sufficientinward-directed pressure is applied to the flexible arm 900. Inaddition, each flexible arm 900 is sufficiently resilient to return toits un-flexed state, when the inward-directed pressure is released

Each flexible arm 900 has a tab 902 that extends outward (radiallyoutward relative to the axis A) from the free end portion 900 a of theflexible arm 900. The tab 902 is shaped to engage or fit into acorrespondingly shaped indentation, opening, groove, stop surface orother engagement structure in the reservoir receptacle 32 of theinfusion pump device 30, when the cap 904 a (or base/reservoir/cap unit)is installed in the reservoir receptacle 32. In the embodiment in FIG.53, the engagement structure includes apertures 908 in an upper ringmember 910 on the open end of the reservoir receptacle 32. Two apertures908 are shown in FIG. 53, to correspond to the two flexible arms 900 inthe embodiment of FIG. 52.

The upper ring member 910 may be attached to the reservoir receptacle 32in any suitable attachment mechanism including, but not limited to,welding, glue, resin or other adhesive material, screw threads, frictionfit, or the like. The upper ring member 910 may be made of any suitablyrigid material, such as but not limited to plastic, metal, ceramic,composite material or combinations thereof. In particular embodiments,the upper ring member 910 corresponds to (or is) the upper ring member94 discussed above with respect to the embodiment in FIG. 7. In otherembodiments, the apertures 908 (or other engagement structure) isprovided directly in or on the housing 33 of the infusion pump device30, for example, within or on one or more wall portions that define thereservoir receptacle 32 of the infusion pump device 30.

In particular embodiments, each flexible arm 900 is formed integral withthe housing 905 of the cap 4, for example, by being molded with the restof the housing 905. In such embodiments, the housing 905 of the cap 904a (and, thus, each flexible arm 900) is made of a material havingsufficient rigidity to hold a shape and operate as described herein, andsufficient flexibility and resiliency to allow each flexible arm 900 toflex inward and return to an un-flexed state, as described herein. Inother embodiments, each flexible arm is a separate element relative tothe housing 905 of the cap 904 a and is attached to the housing 905 byany suitable attachment mechanism including, but not limited to one ormore welds, adhesives, screws, bolts, clamps or the like.

In the embodiment of FIGS. 52 and 53, the cap 904 a (orbase/reservoir/cap unit) is installed in the reservoir receptacle 32 ofthe infusion pump device by inserting the cap 904 a (orbase/reservoir/cap unit) into the open end of the reservoir receptacle32 (or open end of the ring member 910). As the cap 904 a is insertedinto the reservoir receptacle 32, manual pressure may be applied to theflexible arms 900, to squeeze the flexible arms 900 toward each other(toward the axis A). By that action, the flexible arms 900 flex inward,into the gaps 903 by a sufficient amount to allow the tabs 902 to clearupper edge of the reservoir receptacle 32 (or ring member 910) so thatthe cap 904 a (and base/reservoir/cap unit) can be moved further intothe reservoir receptacle 32. As the tabs 902 clear the upper edge andare within the reservoir receptacle 32 (or ring member 910), manualpressure can be released from the flexible arms 900, to allow theresilient, flexible arms 900 to return toward an un-flexed state.However, because the tabs 902 are located within the reservoirreceptacle 32 (or ring member 910), the tabs 902 ride or slide along aninner surface of the reservoir receptacle 32 (or ring member 910), asthe cap 904 a is moved further toward a fully installed position. Whenthe cap 904 a (and base/reservoir/cap unit) are in a fully installedposition within the reservoir receptacle, 32, the tabs 902 on the cap 4align with the apertures 908 in the reservoir receptacle 32 (or ringmember 910). When the tabs 902 align with the apertures 908, the tabs902 fit within the apertures 908 and allow the flexible arms 900 toretract at least partially toward their un-flexed states, for example,due to the resiliency of the flexible arms 900. This action causes thetabs 902 to be retained within the apertures 908, to retain the cap 904a (and base/reservoir/cap unit) in the installed position within thereservoir receptacle 32.

In the embodiment of FIGS. 52-54, to remove the cap 904 a (andbase/reservoir/cap unit) from an installed position within the reservoirreceptacle 32, manual pressure can be applied to ends of tabs 902extending through the openings 908. For example, a squeezing action canbe applied by manually squeezing the tab ends of tabs 902 toward eachother, to flex the flexible arms 900 inward sufficiently to release thetabs 902 from the openings 908. In particular embodiments, a combinationof manual squeezing pressure as noted above with a linear force (alsoapplied manually) to pull the cap 904 a (or base/reservoir/cap unit) ina direction outward from the open end of the reservoir receptacle 32 isapplied to release the tabs 902 from the openings 908. Once the tabs 902are released from the openings 908, further manual force to pull the cap904 a (or base/reservoir/cap unit) in a direction outward from the openend of the reservoir receptacle 32 is applied to withdraw the cap 904 a(and base/reservoir/cap unit) from the reservoir receptacle 32.

In particular embodiments, a locking mechanism is provided on one ormore (or each) of the flexible arms 900, or within one or more (or each)of the gaps 903, to selectively lock the associated flexible arm 900from flexing inward. In particular embodiments, the locking mechanism isconfigured to selectively lock the flexible arm 900, when the tab 902 isengaged with the engagement member (e.g., the aperture 908) in theinfusions pump device 30, to inhibit removal (e.g., accidental orunauthorized) removal of the cap 904 a (or base/reservoir/cap unit) fromthe reservoir receptacle 32. In such embodiments, the locking mechanismis also configured to selective unlock the flexible arm 900 and allowthe flexible arm to flex, to release the tab 902 from the engagementmember. In the embodiment of FIG. 54, the locking mechanism includes amoveable lock member 912 that is located within the gap 903 associatedwith the flexible arm 900. The moveable lock member 912 is arranged tobe moved, in a controlled manner, between first and second positions(shown in solid and broken lines in FIG. 54). In the first position(solid line position in FIG. 54), the moveable lock member 912 islocated further toward the free end 900 a of the flexible arm 900, ascompared to the position of the moveable lock member 912 in the secondposition (broken line position in FIG. 54). When the lock member 912 isin the first position (solid line position in FIG. 54), the flexible arm900 is inhibited from flexing inward by the lock member 912. When thelock member 912 is in the second position (broken line position in FIG.54), the flexible arm 900 is allowed to flex inward, when sufficientinward-directed pressure is applied to the flexible arm 900. Inparticular embodiments, the lock member 912 is controlled to be in thesecond position (broken line position in FIG. 54) during installation orremoval of the cap 904 a (or base/reservoir/cap unit) to or from thereservoir receptacle 32, and is selectively controlled to move to andremain in the first position (solid line position in FIG. 54) when thecap 904 a (or base/reservoir/cap unit) is fully installed within thereservoir receptacle 32.

Movement of the lock member 912 is controlled by any suitable mechanism,including, but not limited to an manual lever, magnetic actuator,electronic solenoid or the like. In particular embodiments, the lockmember 912 is (or includes) a magnetic or magnetically attractablematerial that magnetically interacts with an electromagnet or a moveablemagnet located on or adjacent the outer surface of the cap 904 a. Theelectromagnet is selectively energized (or the moveable magnet isselectively moved) to cause the lock member 912 to move between lockedand unlocked positions (solid and broken line positions in FIG. 54). Infurther embodiments, the lock member 912 may be coupled to a bias member914 (such as, but not limited to a coil spring or other spring), to biasthe lock member 912 toward the locked position (solid line position inFIG. 54), when the lock member 912 is not controlled to move to theunlocked position. In other embodiments, the bias member 914 biases thelock member 912 toward the unlocked position (broken line position inFIG. 54) when the lock member 912 is not controlled to move to thelocked position.

Embodiments described with reference to FIGS. 52-54 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection and opticaldetection) described above. In such embodiments, the cap 904 a or thereservoir 1 (or both) is provided with one or more detectable elements42 as described above, while the ring 910 or other portion of theinfusion pump device 30 is provided with one or more sensor elements 34as described above. In particular embodiments, one or more detectableelements 42 are arranged on the flexible arms 900, or are arranged onthe moveable lock member 912 (or both). In such embodiments, electronics(such as electronics 60) may be configured to detect the relativeposition (state of flex) of the flexible arm(s) 900, or to detect therelative position of the lock member 912 (or both), in addition to or asan alternative to detection of the presence of the cap 904 a (orbase/reservoir/cap unit) or other characteristics and information asdescribed above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap 904 a (or base/reservoir/cap unit) is notproperly received within the reservoir receptacle 32, (2) adetermination that the tabs 902 are not sufficiently engaged with theengagement members 908, and (3) a determination that the lock member 912is in an unlocked position. Such predefined operations include, but arenot limited to one or more of stopping or inhibiting pumping operation,allowing only a limited pumping operation, providing a warning message,and recording data indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap 904a (or base/reservoir/cap unit) is properly received within the reservoirreceptacle 32, (2) a determination that the tabs 902 are engaged withthe engagement members 908, and (3) a determination that the lock member912 is in a locked position. Such predefined operations include, but arenot limited to one or more of allowing or providing pumping operation,allowing a predefined pumping operation, providing a predefined message,and recording data indicating the detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

g. Pivot to Release

In a further embodiment as described with reference to FIG. 55, thesecond releasable coupler includes a pair of pivot members 911 and 913that are pivotally coupled at a pivot point 915 to the cap 904 b. One ormore bias members, such as, but not limited to springs 916 and 918 areprovided to bias the pivot members 911 and 913 into a latched or lockedstate. In the latched state, one end (the lower end in FIG. 55) of eachpivot member 916 and 918 is received within a groove or indentation 32 ein the inner surface 32 b of the reservoir receptacle 32. In that state,the cap 904 b is latched or locked within the reservoir receptacle 32 ofthe infusion pump device 30, to inhibit removal of the cap 904 b (andbase/reservoir/cap unit) from the reservoir receptacle 32.

From that state, one end (the upper end in FIG. 55) of each pivot member916 and 918 may be manually squeezed toward the other pivot member tocause the other end (lower end in FIG. 55) of each pivot member towithdraw from the groove or indentation 32 e by a sufficient amount toallow the user (or medical technician or other authorized person) topull the cap 904 b (and base/reservoir/cap unit) from the reservoirreceptacle, in the direction of axis A.

In a further embodiment as described with reference to FIG. 56, thesecond releasable coupler includes one or more pivot members 920 that ispivotally connected to the housing of the infusion pump device 30, at apivot point 921. One or more bias members 922, such as but not limitedto a spring, is provided to bias the pivot member(s) 920 into a latchedor locked state. In the latched state one end (the lower end in FIG. 55)of each pivot member 916 and 918 is received within a groove orindentation 904 c′ in the outer surface of the cap 904 c. In that state,the cap 904 c is latched or locked within the reservoir receptacle 32 ofthe infusion pump device 30, to inhibit removal of the cap 904 c (andbase/reservoir/cap unit) from the reservoir receptacle 32.

From that state, one end (the lower end in FIG. 56) of the pivot member920 may be manually pushed toward the housing of the infusion pumpdevice 30, to cause the other end (upper end in FIG. 56) of the pivotmember 920 to withdraw from the groove or indentation 904 c by asufficient amount to allow the user (or medical technician or otherauthorized person) to pull the cap 904 c (and base/reservoir/cap unit)from the reservoir receptacle, in the direction of axis A. Embodimentsdescribed with reference to FIGS. 55-56 may be employed with any one ormore of the detection embodiments (magnetic detection, inductivedetection, RF detection, mechanical detection, optical detection andelectrical contact detection) described above. In such embodiments, thecap 904 b or 904 c or the reservoir 1 (or both) is provided with one ormore detectable elements 42 as described above, while the infusion pumpdevice 30 is provided with one or more sensor elements 34 as describedabove.

In particular embodiments, one or more detectable elements 42 arearranged on the pivot member(s) 911, 913 or 920, or on the bias members916, 918 and 922 (or all). In such embodiments, electronics (such aselectronics 60) may be configured to detect the relative position of thepivot member(s) or bias member, in addition to or as an alternative todetection of the presence of the cap 904 b or 904 c (orbase/reservoir/cap unit) or other characteristics and information asdescribed above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap 904 b or 904 c (or base/reservoir/cap unit)is not properly received within the reservoir receptacle 32, and (2) adetermination that the pivot member(s) 911, 913 or 920 are notsufficiently engaged with the groove or indentation 32 e or 904 c′. Suchpredefined operations include, but are not limited to one or more ofstopping or inhibiting pumping operation, allowing only a limitedpumping operation, providing a warning message, and recording dataindicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap 904b or 904 c (or base/reservoir/cap unit) is properly received within thereservoir receptacle 32, and (2) a determination that the pivotmember(s) 911, 913 or 920 are sufficiently engaged with the groove orindentation 32 e or 904 c′. Such predefined operations include, but arenot limited to one or more of allowing or providing pumping operation,allowing a predefined pumping operation, providing a predefined message,and recording data indicating the detection.

In a further embodiment as described with reference to FIGS. 57 and 58,the second releasable coupler includes one or more (or a plurality) ofbiased ball members 930 supported on the infusion pump device 30, andprojecting at least partially into the reservoir receptacle 32 of theinfusion pump device 30. The ball members 930 are arranged to engage oneor more grooves or indentations (one groove is shown at 904 d′ in FIG.57) in the outer surface of the housing of the cap 904 d, when the cap904 d (or base/reservoir/cap unit) is installed in the reservoirreceptacle 32 of the infusion pump device 30.

h. Push-in Lock with Biased Ball Members

In the embodiment in FIGS. 57 and 58, the ball members 930 are supportedin an upper ring member 932 on the open end of the reservoir receptacle32. The upper ring member 932 may be attached to the reservoirreceptacle 32 in any suitable attachment mechanism including, but notlimited to, welding, glue, resin or other adhesive material, screwthreads, friction fit, or the like. The upper ring member 932 may bemade of any suitably rigid material, such as but not limited to plastic,metal, ceramic, composite material or combinations thereof. Inparticular embodiments, the upper ring member 908 corresponds to (or is)the upper ring member 94 discussed above with respect to the embodimentin FIG. 7. In other embodiments, ball members 930 are supported directlyin or on the housing 33 of the infusion pump device 30, for example,within or on one or more wall portions that define the reservoirreceptacle 32 of the infusion pump device 30.

In particular embodiments, the ball members 930 are biased toward theinterior of the reservoir receptacle 32 (toward the axis A), by one ormore bias members. In the embodiment in FIGS. 57 and 58, the biasmembers 934 include springs supported inside of the upper ring member932, as shown in the cross-section view of FIG. 58. In particularembodiments, the upper ring member 932 includes a ball receptacle 936 inwhich a ball member 930 and an associated bias member 934 is supported.The receptacle 936 in the embodiment of FIG. 58 has a tapered shape thatbecomes wider in the direction toward the interior of the reservoirreceptacle 32 (or axis A), forming a tapered collar for receiving a ballmember.

A lip 938 is provided on the inner-facing end of the receptacle 936, toretain the ball member 930 within the tapered collar of the receptacle936. The ball member 930 is held within the receptacle 936, but isbiased, by the bias member 934, against the lip 938, such that a portionof the ball member 930 extends out of the upper ring member 932, towardthe interior of the reservoir receptacle 32. In particular embodiments,the ball member 930 extends into the interior of the reservoirreceptacle 32 by a sufficient distance to engage the outer surface ofthe cap 904 and be received within the groove 904 d′, when the cap 904 d(or base/reservoir/cap unit) is received within the reservoir receptacle32.

When biased against the lip 938, the ball member 930 is spaced from thetapered surface of the receptacle 936, but is moveable toward thetapered surface (against the force of the bias member), when a suitableforce is applied to the outward extended portion of the ball member.

Accordingly, as the cap 904 d (or base/reservoir/cap unit) is insertedinto the reservoir receptacle 32, the ball members 930 engage and slideor ride along the outer surface of the cap 904 d, until the ball members930 engage and are received within the groove 904′ of the cap 904 d. Thegroove 904 d′ and the ball members 930 are arranged relative to eachother, so that the ball members 930 engage and are received within thegroove 904 d′, when the cap 904 d (or base/reservoir/cap unit) reachesits fully installed position within the reservoir receptacle 32.

When engaged with the outer surface of the cap 904 and outside of thegroove 904′, the ball members 930 are pushed against the bias force ofthe bias members 934, and move further into the receptacle 936. However,when the ball members 930 are received within the groove 904 d′, theball members move under the bias force of the bias members 934, towardtheir extended position. This action causes a portion of the ballmembers 934 to extend into the groove 904 d′, to retain the cap 904 d(and base/reservoir/cap unit) in the installed position within thereservoir receptacle 32. To remove the cap 904 d (and base/reservoir/capunit) from an installed position within the reservoir receptacle 32,manual force can be applied to pull the cap 904 d outward from thereservoir receptacle 32 with sufficient force to overcome the bias forceof the bias members 934 on the ball members 930 and force the ballmembers 930 further into the receptacle 936.

In the embodiment of FIGS. 57 and 58, the ball members 930 may becontained within a single ball receptacle 936 that extends annularlywithin the ring member 932 (or within a wall forming a portion of thereservoir receptacle 32). In other embodiments, each ball member 930 maybe contained in a separate receptacle 936. In further embodiments, othershaped members may be used in place of the ball members 930.

In the embodiment of FIGS. 57 and 58, three ball members 930 are shownin view. However, any suitable number of ball members 930 may beemployed. In particular embodiments, either four, five or six ballmembers 930 are employed. In other embodiments, fewer than four or morethan six ball members 930 are employed. In addition, the cap 904 d mayinclude one or more seals 939 (one O-ring seal shown in FIG. 57) on theouter surface of the cap 904 d, between the groove 904 d′ and the openend of the cap 904 d. The seal(s) 939 are arranged to engage the innersurface of the reservoir receptacle 32 and provide a moisture sealbetween the cap 904 d and the inner surface of the receptacle 32 whenthe cap 904 d (or base/reservoir/cap unit) is installed in the reservoirreceptacle 32. (Other embodiments of caps described herein may includeone or more seals similar to the seal 939.)

Embodiments described with reference to FIGS. 57-58 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 904 d or the reservoir 1 (or both) is provided withone or more detectable elements 42 as described above, while theinfusion pump device 30 is provided with one or more sensor elements 34as described above.

In particular embodiments, one or more detectable elements 42 arearranged on a ball member 930, or on a bias member 934 (or both). Insuch embodiments, electronics (such as electronics 60) may be configuredto detect the relative position of the ball member(s) or bias member(s),in addition to or as an alternative to detection of the presence of thecap 904 d (or base/reservoir/cap unit) or other characteristics andinformation as described above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap 904 d (or base/reservoir/cap unit) is notproperly received within the reservoir receptacle 32, and (2) adetermination that the ball member(s) 930 are not sufficiently engagedwith the groove 904 d′. Such predefined operations include, but are notlimited to one or more of stopping or inhibiting pumping operation,allowing only a limited pumping operation, providing a warning message,and recording data indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: 1) a determination that the cap 904d (or base/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) a determination that the ball member(s) 930 aresufficiently engaged with the groove 904 d′. Such predefined operationsinclude, but are not limited to one or more of allowing or providingpumping operation, allowing a predefined pumping operation, providing apredefined message, and recording data indicating the detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

i. Rotatable Ring Lock and Release

In a further embodiment as described with reference to FIGS. 59 and 60,the second releasable coupler includes a rotatable ring member 940mounted at the open end of the reservoir receptacle 32. In FIG. 59, therotatable ring member 940 is shown mounted for rotation in the reservoirreceptacle 32 of the infusion pump device 30. In FIG. 60, the rotatablering member 940 is shown separate from the infusion pump device 30.

The rotatable ring member 940 is connected to the infusion pump device30, but is mounted for rotation around the axis A of the reservoirreceptacle 32 (and of the cap 904 e and base/reservoir/cap unit wheninstalled in the reservoir receptacle 32). For example, an annular edgeportion of the rotatable ring member 940 fits within an annular groovein the inner wall of the reservoir receptacle 32 (or in an upper ringmember attached thereto), where the groove is dimensioned to receive theannular edge portion of the rotatable ring member 940 and allow rotationof the rotatable ring member 940 about the axis A, relative to theinfusion pump device 30. In other embodiments, the rotatable ring member940 may be mounted for rotation by other suitable rotary couplingmechanisms.

In particular embodiments, the rotatable ring member 940 is formed of aplate having a generally annular shaped portion 941 with a centralopening 942 and one or more (or a plurality of) cutouts or slots 943extending radially outward from the edge of the central opening 942. Theembodiment of FIGS. 59 and 60 the rotating ring member 940 also has ahandle or lever portion 944 extending radially outward from an outeredge of the annular portion 941. The handle or lever portion 944 extendsoutward through a slot-shaped (elongated) opening 945 in the infusionpump device 30, in the region of the reservoir receptacle 32, as shownin FIG. 59. The handle or lever portion 944 provides a user interface toallow a user to manually rotate the rotatable ring member 940 relativeto the infusion pump device 30, by manually moving the handle or leverportion 944 to one side or the other (to the left or to the right in thedrawing of FIG. 59).

The central opening 942 in the rotatable ring member 940 is dimensionedmatch or correspond to the outer dimension of a body portion 904 e′ ofthe cap 904 e, to allow the body portion 904 e′ to pass through thecentral opening 942, when the cap 904 e is inserted into the reservoirreceptacle 32, in the direction of the axis A. The cap 904 e alsoincludes one or more (or a plurality of) tab portions 904 e″ extendingradially outward from the body portion of the cap 904 e. In particularembodiments, the number of tab portions 904 e″ is equal to or less thanthe number of cutouts or slots 943 in the rotatable ring 940.

The tab portions 904 e″ are shaped to align with and fit through thecutouts or slots 943, when the cap 904 e (or base/reservoir/cap unit) isinserted into the reservoir receptacle 32. In particular embodiments,the tab portions 904 e″ also align with and fit in corresponding groovesor slots 946 in the inner surface of the reservoir receptacle 32 (or inan inner surface of an upper ring member attached to the reservoirreceptacle 32). In such embodiments, a separate groove or slot 946 ininner wall of the reservoir receptacle 32 is associated with eachdifferent one of the cutouts or slots 943 and aligns with a respectiveone of the cutouts or slots 943, when the cap 904 e (orbase/reservoir/cap unit) is inserted into the reservoir receptacle 32.When the cap 904 e (or base/reservoir/cap unit) is fully inserted intothe reservoir receptacle 32 such that the tap portions 904 e″ havepassed through the cutouts or slots 943 in the rotatable ring 940, thetab portions 904 e″ are abutted against a stop surface or shelf on aninterior surface 948 of the reservoir receptacle 32.

Once the cap 904 e (or base/reservoir/cap unit) is sufficiently insertedinto the reservoir receptacle 32 such that the tab portions 904 e″(having passed through the cutouts or slots 943) are located on the stopsurface or shelf 948, the rotatable ring member 940 may be rotated tomove the cutouts or slots 943 out of alignment with the grooves or slots946. When the cutouts or slots 943 out of alignment with the grooves orslots 946 (while the tabs 904 e″ are within the grooves or slots 946,the cap 904 e is retained within the reservoir receptacle by therotatable ring member 940. To release the cap 904 e, the rotatable ringmember 940 is manually rotated, as described above, to align the cutoutsor slots 943 with the grooves or slots 946. When so aligned, the cap 904e may be manually pulled out from the reservoir receptacle 32, such thatthe tabs 904 e pass back through the cutouts or slots 943 as the cap 904e (or base/reservoir/cap unit) is withdrawn from the reservoirreceptacle 32.

In particular embodiments, the body portion 904 e′ of the cap 904 eincludes one or more (or a plurality of) seal members 947 for sealingagainst a surface 948 in the reservoir receptacle 32. In the embodimentof FIG. 59, an seal member 947 in the form of an O-ring is providedaround the circumference of the body portion 904 e′ of the cap 904 e,between the tabs 904 e″ and the open end of the cap 904 e. The sealmember 947 is arranged engage and form a seal against an inner surfaceof the reservoir receptacle 32 (for example, an inner surface 948 thatis raised inward toward the axis A).

In particular embodiments, only caps (such as cap 904 e) that have tabportions (such as 904 e″) that are equal or less in number and arrangedin a corresponding pattern as the cutouts or slots 943 in the rotatablering member 940 are able to be installed within the reservoir receptacle32 that has the rotatable ring 940. In such embodiments, other caps (notshown) have tab portions that are greater in number or arranged in adifferent pattern (or both) than the cutouts or slots 943 in therotatable ring member 940 and, thus, are not able to fit within thereservoir receptacle 32 of the infusion pump device 30 shown in FIG. 59.However, in such embodiments, one or more other infusion pump devices(similar to infusion pump device 30) is provided with a rotatable ringmember (similar to rotatable ring member 940), but having cutouts orslots 943 corresponding in number and pattern to the tabs on the othercaps, such that, certain caps are configured to fit within certaininfusion pump devices (but not others). Accordingly, a cap 904 esupplied to a particular user may be configured to correspond to aninfusion pump device 30 that is associated with that particular user,but not to an infusion pump device associated with another user.Therefore, a different number and pattern of tabs 904 e″ and number andpattern of cutouts or slots 943 (among a plurality of possible numbersand patterns) may be associated with each different user (among aplurality of users).

While the embodiment in FIGS. 59 and 60 include four equally spacedcutouts or slots 945 and four corresponding equally spaced tabs 904 e″,other embodiments may include any other suitable numbers of cutouts orslots 945 and tabs 904 e″ and/or other suitable spacings thereof.

In a further embodiment as described with reference to FIGS. 61-63, thesecond releasable coupler includes another form of a rotatable ringmember 950 mounted at the open end of the reservoir receptacle 32. InFIG. 61, the rotatable ring member 950 is shown mounted for rotation onthe reservoir receptacle 32 of the infusion pump device 30. In FIG. 62,the rotatable ring member 950 is also shown mounted for rotation on thereservoir receptacle 32 of the infusion pump device 30, but rotated 180degrees relative to the position of the rotatable ring member 950 inFIG. 61. In FIG. 63, the rotatable ring member 950 is shown separatefrom the infusion pump device 30, with the lower side surface (thesurface facing downward in FIGS. 60 and 62) in view.

In the embodiment in FIGS. 61-63, the rotatable ring member 950 has anannular portion 951 with a central opening 952 having a dimension forallowing a cap (or base/reservoir/cap unit) pass through, similar to thecentral opening 943 in the ring member of FIG. 60. In addition, therotatable ring member 950 includes a handle or lever portion 953, formanually rotating the ring member, similar to the manner in which handleportion 944 allows for rotation of the ring member 940 in FIG. 60.However, the ring member 950 in FIGS. 61-63 includes a groove or ribfeature 954 on one surface (the surface facing downward or towards thereservoir receptacle 32 in FIGS. 61 and 62). The groove or rib feature954 extends at least partially around the rotatable ring member 950 andforms a partial spiral, where a first end 954 a of the groove or ribfeature 954 is located radially inward (closer to the axis A) withrespect to the second end 954 b of the groove or rib feature 954. Whenthe rotatable ring member 950 is mounted for rotation on the reservoirreceptacle (as shown in FIGS. 61 and 62), the groove or rib feature 954faces toward the reservoir receptacle 32.

A moveable pin or locking member 956 is supported by the housing 33 ofthe infusion pump device 30 for movement between an extended position(shown in FIG. 61) and a retracted position (shown in FIG. 62). Inparticular embodiments, the moveable pin or licking member 956 is biasedby a bias member 957 (such as a spring or the like) toward the extendedposition. In the extended position (FIG. 61), an end portion 956 a ofthe moveable locking member 956 extends at least partially into thereservoir receptacle 32. In the retracted position (FIG. 62), the endportion 956 a of the moveable locking member 956 is retracted out of thereservoir receptacle 32 (or does not extend as far into the reservoirreceptacle 32 relative to the extended position).

The moveable locking member 956 has a protrusion or extension 956 b thatengages the groove or rib feature 954 of the rotatable ring member 950.In FIGS. 61 and 62, the protrusion or extension 956 b is shown asextending into a groove 954 in the rotatable ring member 950. Theprotrusion or extension 956 b and the groove or rib feature 954 areconfigured such that the protrusion or extension 956 b rides within oralong and is guided by the groove or rib feature 954, as the rotatablering member 950 rotates (e.g., rotates to and between the positionsshown in FIGS. 61 and 62). Because of the spiral shape of the groove orrib feature 954 (extending from a radial inward end 954 a to a radialoutward end 954 b), the moveable locking member 956 is moved to andbetween the extended and retracted positions shown in FIGS. 61 and 62,as the rotatable ring member 950 rotates to and between thecorresponding positions shown in FIGS. 61 and 62.

The moveable locking member 956 is configured to engage a groove,indentation or other stop surface on a cap (or base/reservoir/cap unit),when the cap (or base/reservoir/cap unit) is installed in the reservoirreceptacle 32 and the moveable locking member 956 is in the extendedposition (of FIG. 61). In such embodiments, the cap includes a groove,indentation or other stop surface on the outer surface of the body ofthe cap (for example, but not limited to a groove similar to the groove904 c′ in the cap 904 c in FIG. 56, or the groove 904 d′ in the cap 904d in FIG. 57).

Accordingly, in the embodiment of FIGS. 61-63, to insert a cap (orbase/reservoir/cap unit) into the reservoir receptacle 32, the rotatablering member 950 is rotated to retract the moveable locking member 956 tothe retracted position (shown in FIG. 62). With the moveable lockingmember 956 in the retracted position, the cap (or base/reservoir/capunit) may be inserted through the opening 952 of the rotatable ringmember 950 and at least partially into the reservoir receptacle 32. Oncethe cap (or base/reservoir/cap unit) is fully inserted into thereservoir receptacle (e.g., to a fully installed position), therotatable ring member 950 may be rotated to a position as shown in FIG.61, to move the moveable locking member 956 to the extended position (asshown in FIG. 61). In the extended position, the moveable locking member956 extends into the groove or indentation (or engages the stop surface)on the cap, to retain the cap (and base/reservoir/cap unit) in theinstalled position.

To remove the cap (or base/reservoir/cap unit) from the reservoirreceptacle, the rotatable ring member 950 is rotated to the positionshown in FIG. 62, to move the moveable locking member 956 to theretracted position (as shown in FIG. 62). With the moveable lockingmember 956 in the retracted position, the cap (or base/reservoir/capunit) may be withdrawn from the reservoir receptacle 32 by manuallypulling the cap (or base/reservoir/cap unit) outward from the reservoirreceptacle 32.

Embodiments described with reference to FIGS. 59-63 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 904 b or 904 c or the reservoir 1 (or both) isprovided with one or more detectable elements 42 as described above,while the infusion pump device 30 is provided with one or more sensorelements 34 as described above.

In particular embodiments, one or more detectable elements 42 arearranged on the rotatable ring member 940 or 950, on the tabs 904 e″, onthe moveable locking member 956 or on the bias member 957 (or anycombination thereof). In such embodiments, electronics (such aselectronics 60) may be configured to detect the relative position of therotatable ring member, tabs, moveable locking member or bias member, inaddition to or as an alternative to detection of the presence of the cap(or base/reservoir/cap unit) or other characteristics and information asdescribed above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap (or base/reservoir/cap unit) is not properlyreceived within the reservoir receptacle 32, and (2) a determinationthat the rotatable ring member, movable locking member or bias member isnot in a locking position. Such predefined operations include, but arenot limited to one or more of stopping or inhibiting pumping operation,allowing only a limited pumping operation, providing a warning message,and recording data indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap (orbase/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) a determination that the rotatable ring member,movable locking member or bias member is in a locking position. Suchpredefined operations include, but are not limited to one or more ofallowing or providing pumping operation, allowing a predefined pumpingoperation, providing a predefined message, and recording data indicatingthe detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

i. Pawl Push-in Lock with Pinch Release

In a further embodiment as described with reference to FIGS. 64-66, thesecond releasable coupler includes one or more (or a plurality) of latchpawls that are arranged on the cap 964, to engage one or morecorresponding ribs, grooves, openings, projections or other stop surfacestructures located on the housing 33 of the infusion pump device, butoutside of the reservoir receptacle. When the latch pawls are engagedwith the stop surface structures, the latch pawls secure the cap 964 tothe housing 33 of the infusion pump device 30. In such embodiments, thecap 964 may be configured of a sufficiently flexible and resilientmaterial (plastic or other suitable material) that can be flexed bymanual pressure, to selectively move the latch pawl(s) out of engagementwith the stop surface structure(s) on the infusion pump device 30. Insuch embodiments, when the cap 4 is secured to the housing of theinfusion pump device 30, the cap 964 may be squeezed to release the cap4 from the housing 33.

For example, in the embodiment of FIGS. 64-66, a cap 964 is providedwith a body portion 965 that is sufficiently flexible and resilient toallow a user to manually squeeze the body portion 965 and cause the bodyportion 965 to compress in one dimension (the dimension in which thesqueezing force is directed) and, as a result, to expand in a seconddimension (e.g., a dimension substantially perpendicular to the onedimension). Thus, for example, upon applying a squeezing force in afirst dimension (directed into and out of the page in FIG. 64 anddirected in the dimension of the arrows S in FIG. 66), the body portion965 of the cap 964 expands in a second dimension (directed to the rightand left in FIG. 64, and directed in the dimension of arrows E in FIG.66).

Also in the embodiment of FIGS. 64-66, the cap 964 includes a pluralityof latch pawls 960 (two latch pawls 960 in the illustrated embodiment)provided on the flexible body portion 965 of the cap 964. While twolatch pawls 960 are shown in FIGS. 64-66, other embodiments may havemore than two latch pawls spaced around the inner periphery of the cap964. In the illustrated embodiment, the latch pawls 960 are formed withthe cap body 965, as a single, integral structure, such as, but notlimited to, a molded structure. In other embodiments, the latch pawls960 are separate elements that are attached to the cap body 965.

In the embodiment of FIGS. 64-66, the cap body 965 has an open interiorand an open end (the downward facing end in FIG. 64) that has an innerdiameter that is sufficiently large enough to fit over and outside of anend portion of the reservoir receptacle 32 (or over an upper ring membersecured to the end portion of the reservoir receptacle 32, as describedabove), as shown in FIG. 65. When fitted over the end portion of thereservoir receptacle 32 (or upper ring portion on the reservoirreceptacle 32), the pawls 960 engage with a stop surface 962 on thehousing 33 of the infusion pump device 30 (or on the upper ringportion), to secure the cap 4 (or base/reservoir/cap unit) to theinfusion pump device 30.

In particular embodiment, the pawls 960 have an engagement surface 963that is configured to engage a further engagement surface 966 on thestop surface 962. The diameter of the body 965 of the cap 964 (at leastat the open end of the cap 964) is dimensioned such that the stopsurface 964 of each pawl 960 engages the engagement surface 966 of thestop surface 962, when the cap body 965 is placed over the open end ofthe reservoir receptacle 32. Once the engagement surfaces 963 and 966are engaged, further movement of the cap 964 toward the reservoirreceptacle 32 causes the engagement surface 966 to force the pawls 960radially outward, as the cap 4 (or base/reservoir/cap unit) is movedtoward an installed position with respect to the reservoir receptacle32. The flexible material of the body 965 of the cap 964 allows thepawls 960 to move radially outward under the force of the engagementsurface 966, as the cap 4 (or base/reservoir/cap unit) is moved furthertoward the installed position, until the pawls 960 clear (pass) theengagement surface 966. Once the pawls 960 clear (pass) the engagementsurface 966, the resiliency of the material of the cap body 965 causesthe cap body 965 to contract slightly in the dimension in which thepawls 960 are located, so that the pawls 960 move (or snap) back towardeach other, to engage the housing 33 of the infusion pump device 30,below the stop surface 962. In that arrangement, the pawls 960 retainthe cap 4 on the housing 33 of the infusion pump device 30.

From the installed position (shown in FIG. 65), the cap 964 may beselectively removed from the housing 33 of the infusion pump device 30,by applying a squeezing force on the cap body 965 at a position toexpand the cap body 965 in the dimension in which the pawls 960 arelocated, to selectively move the pawls 960 out of engagement with thestop surface 962. In particular embodiments, the cap body 5 includessurface features 967 at locations at which a squeezing force can beapplied (in the direction of arrows S) to selectively expand the capbody 965 (in the direction of arrows E) to release the pawls 960 fromthe stop surface 962. In this manner, a relatively easy-to-use, and costefficient connection structure may be provided for selectivelyconnecting a cap 964 (or base/reservoir/cap unit) to the reservoirreceptacle 32 of the infusion pump device 30. In particular embodiments,the surface features 967 provide a visually perceptible or a tactilesurface to help a user determine locations to apply a squeezing force onthe cap body 965, to selectively move the pawls 960. In furtherembodiments, the surface features 967 may include a series of bumps,ridges, grooves or combinations thereof, or other surface features oradded materials that increase friction between a user's fingers and thecap body 965 (relative to other portions of the cap body 965).

In the embodiment in FIGS. 64-66, one or both of the engagement surfaces963 and 966 of the pawl 960 and the stop surface 962 has a tapered orsloped surface (sloped relative to the axis A or direction of motion ofthe cap 964 relative to the infusion pump device 30 as the cap 964 isinstalled in the reservoir receptacle), to help to cause the pawls 960to move radially outward when the engagement surfaces 963 and 966 areengaged and pressed together with sufficient force. In addition, one orboth of the pawl 960 and the stop surface 962 may include a secondengagement surface 968 and 969, respectively, that engage each otherwhen the cap 964 (or base/reservoir/cap unit) is in an installedposition, as shown in FIG. 65. The second engagement surfaces 968 and969 are configured to inhibit separation of the cap 964 from the housing33 of the infusion pump device unless the pawls 960 are moved radiallyoutward a sufficient distance (by squeezing the cap body 965 in thedirection of arrows S). In particular embodiments, the second engagementsurfaces 968 and 969 are substantially perpendicular to the axis A. Inother embodiments, the engagement surfaces of the pawls 960 and the stopsurface 962 have other suitable configurations to allow selectiveengagement, retention when engaged and selective disengagement, asdescribed above.

Embodiments described with reference to FIGS. 64-66 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection and opticaldetection) described above. In such embodiments, the cap 964 is providedwith one or more detectable elements 42 as described above, while theinfusion pump device 30 is provided with one or more sensor elements 34as described above.

In particular embodiments, one or more detectable elements 42 arearranged on the pawls 960. In such embodiments, electronics (such aselectronics 60) may be configured to detect the relative position of thepawls 960, in addition to or as an alternative to detection of thepresence of the cap (or base/reservoir/cap unit) or othercharacteristics and information as described above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap (or base/reservoir/cap unit) is not properlyreceived within the reservoir receptacle 32, and (2) a determinationthat the pawls 960 are not in a locking position (or cap-installedposition). Such predefined operations include, but are not limited toone or more of stopping or inhibiting pumping operation, allowing only alimited pumping operation, providing a warning message, and recordingdata indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap (orbase/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) determination that the pawls 960 are in a lockingposition (or cap-installed position). Such predefined operationsinclude, but are not limited to one or more of allowing or providingpumping operation, allowing a predefined pumping operation, providing apredefined message, and recording data indicating the detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

k. Push-in Lock with Expandable Ring Member

In a further embodiment as described with reference to FIGS. 67-68, thesecond releasable coupler includes an expandable ring member 970 that isarranged in or on the reservoir receptacle 32 of the infusion pumpdevice 30 (or in or on an upper ring member attached to the reservoirreceptacle 32 as described herein). The expandable ring member 970 isarranged to be engaged by an engagement feature 972 on the cap 974 (orbase/reservoir/cap unit), as the cap 974 (or base/reservoir/cap unit) ismoved into the reservoir receptacle 32 of the infusion pump device 30.In such embodiments, the expandable ring member 970 expands to allow theengagement feature 972 on the cap 974 to move through a gap 973 in thering member 970 and clear (pass) the ring member 970, as the cap 974 (orbase/reservoir/cap unit) is moved into the reservoir receptacle 32,toward an installed position. Once the engagement feature 972 clears(passes) through the gap 973 in the ring member 970, the ring member 970contracts back to its original (unexpanded) state and inhibits theengagement feature 972 from passing back through the gap 973, to retainthe cap 974 (or base/reservoir/cap unit) in the reservoir receptacle 32.

In the embodiment of FIGS. 67-68, the expandable ring member 970 has agenerally annular shape, with a gap 973 provided between two ends 970 aand 970 b. The ring member 970 is made of a material that is resilientlyexpandable and can expand from a first state to open the gap 973 further(increase the width of the gap 973) relative to the first state when asufficient force is applied to the two ends 970 a and 970 b of the ringmember 970 in a direction of spreading the two ends 970 a and 970 bapart. In addition, the ring member 970 is sufficiently resilient, toreturn to its first state (unexpanded state), when the force is releasedfrom the two ends 970 a and 970 b of the ring member 970. The ringmember 970 may be made of any suitable material that is sufficientlyflexible and resilient to expand and contract as described herein, suchas, but not limited to a spring metal or other metal, plastic, ceramicor composite material, or any combination thereof.

The ring member 970 is held within the reservoir receptacle 32 and, inparticular embodiments, is fixed to the interior surface of thereservoir receptacle 32 (or to an upper ring member attached to theupper end of the reservoir receptacle). The ring member 970 may besecured to the housing 33 of the infusion pump device 30 (or upper ringmember) by any suitable securing mechanism and, in particularembodiments, is keyed with the housing 33 of the infusion pump device 30to inhibit rotation of the ring member 970 relative to the housing 33.In the illustrated embodiment, the ring member 970 includes a key tab orprotrusion 976 that fits within a correspondingly shaped key slot orindentation 978 in the housing 33 of the infusion pump device 30, toinhibit rotation of the ring member 970. In other embodiments, theplacement of the key tab and the key slot is reversed, such that the keytab is on the housing 33 and the key slot is on the ring member 970. Inother embodiments, other suitable keyed engagement features are providedon the ring member 970 and the housing 33 of the infusion pump device30, to inhibit rotation of the ring member 970.

In the embodiment of FIG. 67, the engagement feature 972 on the cap 974includes a protruding portion that protrudes outward from the surface ofthe cap housing 975. The protruding portion of the engagement feature972 includes a tapered section 972 a that has a relatively smaller widthor pointed end toward the open end of the cap 974 (the lower end of thecap 974 in FIG. 67) and increases in width toward the port 6 end of thecap 974. In the illustrated embodiment, the tapered section 972 a has atriangular or arrow-head like shape. Also in the illustrated embodiment,the protruding portion of the engagement feature 972 includes agenerally linear section 972 b that extends from the tapered section 972a, toward the port 6 end of the cap 974. The generally linear section972 b has a width dimension that is greater than the width of thesmallest width or pointed end of the tapered section 972 a, and smallerthan the greatest width end of the tapered section 972 a. In particularembodiments, the engagement feature 972 is formed with the rest of thebody 975 of the cap 974, as a single, integrated structure, for example,but not limited to, a molded structure. In other embodiments, theengagement feature 972 is a separate element that is attached to thebody 975 of the cap 974.

The tapered section 972 a of the engagement feature 972 is configured tofit into and through the gap 973, as the cap 974 (or base/reservoir/capunit) is moved into the reservoir receptacle 32, toward an installedposition. The tapered shape of the tapered section 972 a helps to alignthe tapered section 972 a with the gap 973 (and to align the cap 974 orbase/reservoir/cap unit in a proper installation alignment position withthe infusion pump device 30. The widest end of the tapered section 972 a(the end closes to the port 6 end of the cap 4) has a stop surface 972 cthat engages the ring member 970, after the tapered section 972 a passesthrough the gap 973. The stop surface 972 c, when engaged with the ringmember 970, inhibits removal of the cap 974 (or base/reservoir/cap unit)from the reservoir receptacle 32. When the tapered section 972 a ispassed through the gap 973, the linear section 972 b of the engagementfeature is disposed within the gap 973 and inhibits rotation of the cap974 (and base/reservoir/cap unit) relative to the ring member 970 (and,thus, relative to the infusion pump device 30).

In the embodiment of FIGS. 67-68, the ends 970 a and 970 b on eitherside of the gap 973 are tapered or sloped relative to the direction ofthe axis A. As shown in FIGS. 67-68, the tapered or sloped ends 970 aand 970 b form a gap 973 that has a first width d₁ and a second widthd₂, where the first width d₁ is located further into the reservoirreceptacle 32 and is smaller than the second width d₂. The tapered orsloped ends 970 a and 970 b further help to align the engagement feature972 on the cap 974 with the gap 974 and help to convert linear motion ofthe cap 974 (or base/reservoir/cap unit) in the installation directionof axis A into a force to expand the ring member 970, as the engagementfeature 972 passes through the gap 973.

In particular embodiments, the ring member 970 is provided with one ormore arms or levers (not shown) or other features that are manuallyoperable by a user to selectively expand the gap 973. In suchembodiments, once the cap 974 (or base/reservoir/cap unit) has beeninstalled in the reservoir receptacle 32 such that the engagementfeature 972 has passed through the gap 973 in the ring member 970, thering member 970 may be selectively expanded (with manual force on thearms or levers) to allow the cap 974 to be manually pulled outward fromthe reservoir receptacle 32 to remove the cap 974 (or base/reservoir/capunit) from the reservoir receptacle 32.

Embodiments described with reference to FIGS. 67-68 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 974 is provided with one or more detectableelements 42 as described above, while the infusion pump device 30 isprovided with one or more sensor elements 34 as described above.

In particular embodiments, one or more detectable elements 42 arearranged on the ring member 970 or the engagement feature 972 (or both).In such embodiments, electronics (such as electronics 60) may beconfigured to detect the relative position of the ring member 970 orengagement feature 972, in addition to or as an alternative to detectionof the presence of the cap (or base/reservoir/cap unit) or othercharacteristics and information as described above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap (or base/reservoir/cap unit) is not properlyreceived within the reservoir receptacle 32, and (2) a determinationthat the ring member 970 or engagement feature 972 is not in a lockingposition (or cap-installed position). Such predefined operationsinclude, but are not limited to one or more of stopping or inhibitingpumping operation, allowing only a limited pumping operation, providinga warning message, and recording data indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap (orbase/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) determination that the ring member 970 orengagement feature 972 is in a locking position (or cap-installedposition). Such predefined operations include, but are not limited toone or more of allowing or providing pumping operation, allowing apredefined pumping operation, providing a predefined message, andrecording data indicating the detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

l. Slot and Tab Connection

In a further embodiment as described with reference to FIGS. 69-71, thesecond releasable coupler includes a compressible ring member 980 thatis held within the interior of the reservoir receptacle 32 of theinfusion pump device 30, adjacent the open end of the reservoirreceptacle 32. In the illustrated embodiment, the compressible ringmember 980 fits within an annular groove or notch 981 provided on theinner surface of the reservoir receptacle 32. The compressible ringmember 980 has an uncompressed state (shown in FIG. 69) and a compressedstate (shown in FIG. 70). In the uncompressed state (FIG. 69), thecompressible ring member 980 includes a central opening 980 a throughwhich at least a portion of the cap 984 (or base/reservoir/cap unit)pass, as the cap 984 (or base/reservoir/cap unit) is installed in orwithdrawn from the reservoir receptacle 32. The compressible ring member980 may be made of any suitable compressible material, such as, but notlimited to, a resiliently compressible rubber, silicone rubber, orplastic material, or the like.

An upper ring member 982 is configured to fit over the open end of thereservoir receptacle 32 and includes threads 983 (or other suitableconnection structure) to secure to the outer surface of the housing 33of the infusion pump device 30, adjacent the open end of the reservoirreceptacle 32, for example. The upper ring member 982 may be made of anysuitably rigid material such as, but not limited to a generally rigidplastic, metal, ceramic, wood or composite material, or any combinationthereof. The upper ring member 982 includes a central opening 982 athrough which at least a portion of the cap 984 (or base/reservoir/capunit) pass, as the cap 984 (or base/reservoir/cap unit) is installed inor withdrawn from the reservoir receptacle 32. The upper ring member 982also includes a ledge or lip portion 982 b that surrounds the centralopening 982 a and overlaps and abuts at least a portion of thecompressible ring member 980.

The threads 983 on the upper ring member 982 are arranged to threadinglyengage corresponding threads 986 on the outer surface of the housing 33of the infusion pump device 30, around the open end of the reservoirreceptacle 32. Accordingly, the upper ring member 982 secures to thehousing 33 of the infusion pump device 30 (via threads 983 and 986, orother suitable connection structure) and helps retain the compressiblering member 980 within the groove or notch 981 in the reservoirreceptacle 32. Furthermore, as described herein the upper ring member982 may be rotated about the axis A in a first direction and selectivelythreaded further onto the housing 33 to selectively compress thecompressible ring member 980 between the ridge or lip 982 b of the upperring member 982 and the groove or notch 981 in the reservoir receptacle32. From that state, the upper ring member 982 may be rotated about theaxis A in a second direction opposite to the first direction, toselectively de-compress the compressible ring member 980.

When the compressible ring member 980 is in an uncompressed state (asshown in FIG. 69), the central opening 980 a in the compressible ringmember 980 has a diameter large enough (e.g., larger than the outerdiameter of the cap 984 and base/reservoir/cap unit) to allow the cap984 (and base/reservoir/cap unit) to pass at least partially through thecentral opening 980 a, to install or withdraw the cap 984 (orbase/reservoir/cap unit) to or from the reservoir receptacle 32. In theuncompressed state, the cap 984 (or base/reservoir/cap unit) may bemoved into the reservoir receptacle 32, by passing the cap (orbase/reservoir/cap unit) through the central openings 980 a and 982 a inthe compressible ring member 980 and the upper ring member 982, to aposition at which a portion of the body 985 of the cap 984 is laterallyadjacent to the compressible ring member 980. Then, the upper ringmember 982 is rotated in a direction to compress the compressible ringmember 980 in the direction of the axis A.

When the compressible ring member 980 is in a compressed state (as shownin FIG. 70), the compressible ring member 980 is compressed in thedirection of the axis A, but is expanded inward toward the axis A, toreduce the diameter of the central opening 980 a. By threading the upperring member 982 a sufficient amount onto the housing 33 of the infusionpump device 30, the upper ring member 982 compresses the compressiblering member 980 to reduce the diameter of the central opening 980 a byan amount to cause the ring member 980 to engage and abut the outersurface of the cap body 985 with sufficient force to retain the cap 984(or base/reservoir/cap unit) within the reservoir receptacle 32 (asshown in FIG. 70).

In particular embodiments, one or both of the upper ring member 982 andthe compressible ring member 980 is provided with one or more (or aplurality) of notches or slots 988 and 987, respectively, that have ashape and size that receive a corresponding one or more (or a plurality)of tabs or protrusions 989 on the body 985 of the cap 984. In theillustrated embodiment, the upper ring member 982 and the compressiblering member 980, each have two slots, while the cap 984 has twocorresponding tabs 989. In other embodiments, more than two slots andtabs may be provided on the respective components. In yet otherembodiments, the locations of the slots and tabs are reversed, such thatthe slots are on body 985 of the cap 984 and the tabs or projections areon the upper ring member 982 and the compressible ring member 980. Theslots and tabs help to align the cap 984 (and base/reservoir/cap unit)in a predefined rotational position relative to the axis A, duringinstallation or removal of the cap 984 (or base/reservoir/cap unit) inor from the reservoir receptacle 32. Accordingly, the slots and tabs maybe arranged to orient the cap 984 (and base/reservoir/cap unit) in aproper rotational or angular orientation relative to the axis A, whenthe cap 984 (or base/reservoir/cap unit) is installed in the reservoirreceptacle 32.

In a further embodiment as described with reference to FIGS. 72 and 73,the second releasable coupler includes an upper ring member 990 that isattached to the open end of the reservoir receptacle 32 of the infusionpump device 30, for example, in a manner similar to the manner in whichother upper ring members described herein are attached to the infusionpump device, or other suitable manner. The upper ring member 990includes a central opening 990 a, through which at least a portion ofthe cap 994 (or base/reservoir/cap unit) pass, as the cap 994 (orbase/reservoir/cap unit) is installed in or withdrawn from the reservoirreceptacle 32. The upper ring member 990 may be made of any suitablyrigid material such as, but not limited to a generally rigid plastic,metal, ceramic, wood or composite material, or any combination thereof.

In the embodiment of FIG. 72, the upper ring member 990 has a ridge orlip portion 990 b provided with one or more (or a plurality) of notchesor slots 990 c, respectively, that have a shape and size that receive acorresponding one or more (or a plurality) of tabs or protrusions 991 onthe body 995 of the cap 994, when the cap 994 (or base/reservoir/capunit) is passed at least partially through the central opening 990 a ofthe upper ring member 990. In the illustrated embodiment, the upper ringmember 990 has two slots, while the cap 994 has two corresponding tabs991. In other embodiments, more than two slots and tabs may be providedon the respective components.

In the embodiment of FIG. 72, the portion of the housing 33 of theinfusion pump device 30 that defines the interior wall of the reservoirreceptacle 32 is provided with an annular shelf 996 and one or more (ora plurality) of channels 997 extending through the annular shelf 996 andinto the interior wall of the reservoir receptacle 32 below the annularshelf 996. The annular shelf 996 extends around the axis A and may beformed as part of the upper rim of the housing 33 at the reservoirreceptacle, or may be formed as a further surface feature on the innerwall of the reservoir receptacle 32 below the upper rim of the housing33. In the embodiment of FIG. 72, two channels 997 are provided (oneshown in view, and the other out of view but shown in broken lines as ifbeing viewed through the housing 33 of the infusion pump device 30). Inother embodiments, more than two channels 997 may be provided.

To install the cap 994 (or base/reservoir/cap unit) in the reservoirreceptacle 32, The cap 994 (or base/reservoir/cap unit) is moved alongthe direction of the axis A, through the opening 990 in the upper ringmember 990. As the cap 994 is moved along the direction of the axis A,the cap 994 is manually rotated about the axis A to align the tabs 991on the cap 994 with the slots 990 c in the upper ring member 990, sothat the tabs 991 pass through the slots 990 c. Once the tabs 991 passthrough the slots 990 c, the tabs 991 engage the shelf 996 and inhibitfurther movement of the cap 994 into the reservoir receptacle 32, untilthe tabs 991 are aligned with the open ends of the channels 997. Morespecifically, once the tabs are engaged with the shelf 996, the cap 994is manually rotated further manually rotated about the axis A, while thetabs ride along the top of the shelf 996, to align the tabs 991 with theopen ends of the channels 997. In particular embodiments, one or moreprotrusions, walls or other features 998 is provided at one or morelocations along the shelf 996, to be engaged by the tabs 991 and stopfurther rotational motion of the cap 994 (or base/reservoir/cap unit) inone direction around the axis A. The stop feature(s) 998 inhibit furtherrotation in one direction, to help the user align the tabs 991 with theopen ends of the channels 997.

Once the tabs 991 are aligned with the open ends of the channels 997,the cap 994 (and base/reservoir/cap unit) is manually moved in thedirection of axis A, further into the reservoir receptacle 32, toward afully installed position. As shown in FIG. 72, the channels 997 extendfrom their open ends, downward, further into the reservoir receptacle 32and partially around the axis A. Accordingly, the tabs 991 follow thechannels 997 downward and partially around the axis A, as the cap 994(and base/reservoir/cap unit) is rotated partially about the axis A andmoved toward an installed position.

When the tabs 991 reach the lower end of the channels 997, the cap 994(and base/reservoir/cap unit) is in the fully installed position withinthe reservoir receptacle 32. In particular embodiments, the lower end ofthe channels 997 includes a further recess or stop surface that isengaged by the tabs 991, when the tabs reach the lower end of thechannels 997, and provides tactile feedback to the user, indicating thatthe tabs 991 have reached the end of the channels 997 (and the cap orbase/reservoir/cap unit is in the fully installed position).

From the fully installed position, the cap 994 (and base/reservoir/capunit) may be removed from the reservoir receptacle by manually rotatingthe cap 994 about the axis A in a direction to cause the tabs 991 tofollow the channels 997 toward the open end of the channels 997, whilesimultaneously pulling the cap 994 outward from the reservoir receptacle32. When the tabs 991 reach the open ends of the channels 997, the cap994 is further manually rotated about the axis A to align the tabs 991with the slots 990 c. Once the tabs 991 are aligned with the slots 990c, further pulling of the cap 994 outward from the reservoir receptacle332 causes the cap 994 (and base/reservoir/cap unit) to be withdrawnfrom the reservoir receptacle 332, through the opening 990 a in theupper ring member 990.

In the embodiment of FIG. 72, the tabs 991 may be arranged on legportions 999 that extend from the body 995 of the cap 994, below theopen end (lower end in FIG. 72) of the cap 994. The leg portions 999locate the tabs 991 a sufficient distance from the open end of the cap994, to engage the channels 997 in the reservoir receptacle 32 (belowthe upper ring member 990), while a portion of the cap 994 extendsoutward from the opening 990 a of the upper ring member 990.

In other embodiments, the legs 999 are omitted and the tabs 991 arearranged on the body 995 of the cap 994. In such embodiments, thechannels 997 may be located in the upper ring member 990 (instead of thehousing 33 of the infusion pump device 30), and the lip 990 b of theupper ring member 990 may be omitted, as shown in FIG. 73.

In the embodiments of FIGS. 72 and 73, the open, upper ends of thechannels 997 are tapered or flared to be wider than other portions ofthe channels. The tapered or flared upper ends of the channels 997 canhelp the user to align the tabs 991 with the open ends of the channelsduring installation of the cap 994 (or base/reservoir/cap unit) in thereservoir receptacle 32.

Embodiments described with reference to FIGS. 69-73 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 984 or 994 is provided with one or more detectableelements 42 as described above, while the infusion pump device 30 isprovided with one or more sensor elements 34 as described above.

In particular embodiments, one or more detectable elements 42 arearranged on the tabs 989, compressible ring member 980, or upper ringmember 982. In such embodiments, electronics (such as electronics 60)may be configured to detect the relative position of the tabs 989,compressible ring member 980 or upper ring member 982, in addition to oras an alternative to detection of the presence of the cap (orbase/reservoir/cap unit) or other characteristics and information asdescribed above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap (or base/reservoir/cap unit) is not properlyreceived within the reservoir receptacle 32, and (2) a determinationthat the tabs 989, compressible ring member 980 or upper ring member 982is not in a locking position (or cap-installed position). Suchpredefined operations include, but are not limited to one or more ofstopping or inhibiting pumping operation, allowing only a limitedpumping operation, providing a warning message, and recording dataindicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap (orbase/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) determination that the tabs 989, compressiblering member 980, or upper ring member 982 is in a locking position (orcap-installed position). Such predefined operations include, but are notlimited to one or more of allowing or providing pumping operation,allowing a predefined pumping operation, providing a predefined message,and recording data indicating the detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

m. Spring Connection

In a further embodiment as described with reference to FIGS. 74 and 75,the second releasable coupler includes one or more (or a plurality of)moveable members 1000 supported by the housing 33 of the infusion pumpdevice 30, and arranged to at least partially extend into the reservoirreceptacle 32. The embodiment of FIG. 74 includes two moveable members1000. Other embodiments include more than two moveable members 1000arranged around the axis A, within the reservoir receptacle 32. Eachmoveable member 1000 is supported on or in an interior wall portion ofthe reservoir receptacle, and is biased by a bias member 1002 toward thecenter of the reservoir receptacle 32 (toward the axis A). In particularembodiments, the bias member 1002 is a spring, such as, but not limitedto, a coil spring, a leaf spring, or the like, arranged between themoveable member 1000 and a portion of the housing 33 of the infusionpump device 30. Each moveable member 1000 may be composed of a rigidbody having a pin or pellet shape (or other suitable shape), and made ofany suitably rigid material such as, but not limited to plastic, metal,ceramic, wood, composite material or any combination thereof.

In the illustrated embodiment, each moveable member 1000 is locatedwithin a groove, depression, or indentation 1003 in an interior wallportion of the reservoir receptacle 32. In the illustrated embodiment,the grooves, depressions, or indentations 1003 are provided in thehousing 33 of the infusion pump device. In other embodiments, thegrooves, depressions, or indentations 1003 (and the moveable members1000 and bias members 1002) are located in an upper ring member (notshown) that connects to the upper end of the housing 33 at the reservoirreceptacle 32, for example, similar to the manner in which other upperring members described herein connect to the housing 33.

Each moveable member 1000 is arranged to engage and contact a flexiblespring member 1006 on the outer surface of the body 1005 of a cap 1004,when the cap 1004 (or base/reservoir/cap unit) is moved into thereservoir receptacle 32, in the direction of the axis A. The flexiblespring member 1006 is connected to the cap body 1005 and extends awayfrom the open end (lower end in FIGS. 74 and 75) of the cap 1004, whileinclining or flaring outward. In particular embodiments, a single springmember 1006 extends around the cap body 1005 (around the axis A), toengage the moveable members 1000 in any rotary position of the cap 1004(and base/reservoir/cap unit) relative to the reservoir receptacle 32(and axis A). In other embodiments, a plurality of spring members 1006corresponding in number and location to a plurality of moveable members1000 are arranged around the perimeter of the cap body 1005, to engagethe corresponding plurality of moveable members 1000 when the cap 1004(or base/reservoir/cap unit) is moved into the reservoir receptacle 32,in the direction of the axis A.

In particular embodiments, one or more pairs of spring members 1006 arearranged on the cap body 1005 such that the two spring members 1006 ineach pair are located on opposite sides of the axis A relative to eachother. In such embodiments, the two spring members 1006 in a given pairprovide radially-directed spring forces in opposite directions, to helpretain the cap 1004 (or base/reservoir/cap unit) stable within thereservoir receptacle. In yet other embodiments, each different cap 1004has a different arrangement of spring members 1006 (e.g., a differentnumber or pattern of locations on the cap body 1005) with respect toother caps 1004, where the different arrangements correspond todifferent respective characteristics of the cap 1004 (or base/reservoircap unit or infusion set connected thereto), as described above withrespect to other embodiments having different features corresponding todifferent characteristics.

In the embodiment of FIGS. 74 and 75, when the cap 1004 (orbase/reservoir/cap unit) is inserted into the reservoir receptacle 32and moved in the direction of the axis A toward an installed position,the moveable members 1000 in the reservoir receptacle 32 engage theflexible springs 1006 on the cap 1004. As the cap 1004 (orbase/reservoir/cap unit) is moved further into the reservoir receptacletoward the installed position, the moveable members 1000 press againstthe spring member(s) 1006 and force the outward extending of flaredend(s) of the spring member(s) toward the cap body 1005, until thespring member(s) 1006 are moved past the moveable members 1000. When thecap 1004 (or base/reservoir/cap unit) has moved to a fully installedposition in the reservoir receptacle 32, the spring member(s) 1006 onthe cap body 1005 have moved past the moveable members 1000, and thespring member(s) 1006 have returned to their non-pressed state, as shownin FIG. 75. In that state, the moveable members 1000 are biased (by thebias members 1002) outward, over the spring member(s) 1006, to aposition to engage the spring member(s) 1006 and inhibit movement of thecap 1004 (or base/reservoir/cap unit) in a direction to withdraw the cap(or base/reservoir/cap unit) from the reservoir receptacle 32.

From the installed position, the cap 1004 (or base/reservoir/cap unit)may be selectively withdrawn from the reservoir receptacle, byselectively moving the moveable members 1000 radially outward asufficient distance to allow the spring member(s) 1006 to pass by themoveable members 1000, while applying a manual force to pull the cap1004 in the direction of axis A, outward from the reservoir receptacle32. In particular embodiments, a mechanism for selectively moving themoveable members 1000 radially outward is provided in the housing 33 ofthe infusion pump device 30, where such mechanism may include, but isnot limited to, a magnetic or electromagnetic solenoid, a manuallymovable lever on the bias members 1002 or other suitable mechanism.

The moveable members 1000 are configured with a first surface facingtoward the open end of the reservoir receptacle (facing upward in FIGS.74 and 75) and a second surface facing inward, into the reservoirreceptacle 32 (facing downward in FIGS. 74 and 75). In particularembodiments, the first surface of the moveable member 1000 is tapered,sloped or curved (forming one or more oblique angles relative to theaxis A) to enhance the ability of the spring member(s) 1006 to engageand move the moveable members radially outward, as the cap 1004 (orbase/reservoir/cap unit) is moved in the direction of axis A into thereservoir receptacle 32. In further embodiments, the second surface ofthe moveable member 1000 is generally perpendicular to the axis A (orhas another suitable shape) to inhibit movement of the spring member(s)1006 past the moveable members 1000, when the cap 1004 (orbase/reservoir/cap unit) is in the fully installed position (as shown inFIG. 75).

In particular embodiments, one or more seal members 1008 is provided onthe cap 1004, for example, around the perimeter of the cap body 1005,adjacent to the open end of the cap body 1005. In such embodiments, theone or more seal members 1008 are configured to contact and seal againstan interior surface of the reservoir receptacle 32, when the cap 1004(or base/reservoir/cap unit) is installed within the reservoirreceptacle 32. The seal member 1008 may be any suitable seal structureincluding, but not limited to an O-ring or band of seal material asdescribed herein.

Embodiments described with reference to FIGS. 74-75 may be employed withany one or more of the detection embodiments (magnetic detection,inductive detection, RF detection, mechanical detection, opticaldetection and electrical contact detection) described above. In suchembodiments, the cap 1004 is provided with one or more detectableelements 42 as described above, while the infusion pump device 30 isprovided with one or more sensor elements 34 as described above.

In particular embodiments, one or more detectable elements 42 arearranged on the tabs 991, legs 999, moveable members 1000, bias members1002 or spring members 1006. In such embodiments, electronics (such aselectronics 60) may be configured to detect the relative position of thetabs 991, legs 999, moveable members 1000, bias members 1002 or springmembers 1006, in addition to or as an alternative to detection of thepresence of the cap (or base/reservoir/cap unit) or othercharacteristics and information as described above.

In such embodiments, electronics 60 in the infusion pump device may beconfigured to provide one or more predefined operations, at leastpartially based on (or in response to) one or more of: (1) adetermination that the cap (or base/reservoir/cap unit) is not properlyreceived within the reservoir receptacle 32, and (2) a determinationthat the tabs 991, legs 999, moveable members 1000, bias members 1002 orspring members 1006 are not in a locking position (or cap-installedposition). Such predefined operations include, but are not limited toone or more of stopping or inhibiting pumping operation, allowing only alimited pumping operation, providing a warning message, and recordingdata indicating the detection.

Alternatively or in addition, the electronics 60 may be configured toprovide one or more predefined operations, at least partially based on(or in response to) one or more of: (1) a determination that the cap (orbase/reservoir/cap unit) is properly received within the reservoirreceptacle 32, and (2) determination that the tabs 991, legs 999,moveable members 1000, bias members 1002 or spring members 1006 is in alocking position (or cap-installed position). Such predefined operationsinclude, but are not limited to one or more of allowing or providingpumping operation, allowing a predefined pumping operation, providing apredefined message, and recording data indicating the detection.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

n. Push-Fit with Spring-Loaded Reservoir or Cap

In further examples of any of the embodiments described herein, thereservoir receptacle 32 of the infusion pump device 30 may include aspring or other bias member (such as bias member 1000 in FIGS. 76 and77) that imparts a bias force on a reservoir (e.g., reservoir 1, 201 or301 or other suitable reservoir) or a cap (e.g., cap 4, 204, 404, 504,704, 804, 904 a-e, 964, 974, 984, 994, 1004, or other suitable cap) inthe direction of the longitudinal axis of the reservoir receptacle 32(axis A) and outward from the reservoir receptacle 32, when thebase/reservoir/cap unit is installed in the reservoir receptacle 32. Theuser (or medical technician or other authorized person) installs abase/reservoir/cap unit in the reservoir receptacle 32 by inserting thebase/reservoir/cap unit, reservoir-end first, into the reservoirreceptacle 32 and pushing the cap against the force of the spring orother bias member, to move the base/reservoir/cap unit further into thereservoir receptacle 32.

In such further examples, the cap includes a latching or lockingstructure to latch or lock the cap to the infusion pump device 30,against the bias force of the spring or other bias member, when the cap(or base/reservoir/cap unit) is fully and properly received in thereservoir receptacle 32. Various examples of such latching or lockingstructure are described herein, where a predefined manual action can becarried out to selectively unlatch or unlock the cap (orbase/reservoir/cap unit) from a latched or locked state, to allow thecap (or base/reservoir/cap unit) to be withdrawn from the reservoirreceptacle 32. In particular embodiments, when the cap (orbase/reservoir/cap unit) is in a latched or locked state, the force ofthe spring or other bias member helps to lock and maintain the cap (andbase/reservoir/cap unit) in a predefined position within the reservoirreceptacle 32.

According to certain embodiments, the spring or other bias member isconfigured such that the cap (or base/reservoir/cap unit) is at leastpartially ejected from the reservoir receptacle 32 by the force of thespring or other bias member, upon unlatching or unlocking of the cap (orbase/reservoir/cap unit) from the latched or locked state. By partiallyejecting the cap (or base/reservoir/cap unit) from the reservoirreceptacle 32, the reservoir 1, 201, 301 is moved out of operativealignment with the drive mechanism within the reservoir receptacle 32and, thus, will not be operated by the infusion pump device (unless anduntil the cap or base/reservoir/cap unit is again placed in a latched orlocked state). Alternatively or in addition, by partially ejecting thecap (or base/reservoir/cap unit) from the reservoir receptacle 32, thecap (or base/reservoir/cap unit) can be easier to manually grip tofurther withdraw the cap (or base/reservoir/cap unit) from the reservoirreceptacle 32.

FIG. 76 shows a portion of the reservoir receptacle 32 of an infusionpump device 30, with a base/reservoir/cap unit received in the interiorvolume of the reservoir receptacle 32. Only an end portion of thereservoir of the base/reservoir/cap unit is shown in FIG. 76. Thereservoir in FIG. 76 may be the reservoir 1, 201 or 301 coupled to orincluding any of the cap embodiments (4, 204, 404, 504, 704, 804, 904a-e, 964, 974, 984, 994, 1004) described herein. In the exampleembodiment of FIG. 76, the infusion pump device 30 includes a biasmember 1010 in the form of a coil spring located at or near the closedend (the bottom end in FIG. 76) of the reservoir receptacle 32, toimpart a bias force on the reservoir (and to the cap coupled to thereservoir) toward the port end of the reservoir receptacle 32, in thedirection of arrow 1012 and the axis A (upward in FIG. 76), when thebase/reservoir/cap unit is installed in the reservoir receptacle 32.

In the embodiment of FIG. 76, the bias member 1010 engages and imparts abias force on an end surface 1 c of the reservoir 1, 201, 301. The biasmember 1010 is supported by a stop surface 32 a of the reservoirreceptacle 32. Thus, in the example embodiment in FIG. 76, one end ofthe coil spring that forms the bias member 1010 is arranged to abutagainst and impart a bias force on the end surface 1 c of the reservoir1, while a second end of coil spring is arranged to abut against and besupported by the stop surface 32 a. In other embodiments, an engagementmember is interposed between the bias member 1010 and the end surface 1c of the reservoir 1 or the stop surface 32 a of the reservoirreceptacle 32 (or both), such that the bias member 1010 does not makedirect contact with the end surface 1 c or the stop surface 32 a (orboth).

In the embodiment of FIG. 76, the stop surface 32 a is the end surfaceof the reservoir receptacle at the close end thereof. In otherembodiments, the stop surface 32 a is another surface provided in thereservoir receptacle, such as, but not limited to, a surface of anextension, protrusion, groove, indentation, or other structural featureprovided on an inner surface 32 b of the reservoir receptacle 32, or onthe inner surface of the end of the reservoir receptacle 32.

In further example embodiments, as shown in FIG. 77, the bias member1010 engages and imparts a bias force on a surface 4 a of a cap 4 (or204, 404, 504, 704, 804, 904 a-e, 964, 974, 984, 994, or 1004). Only aportion of the cap, reservoir and the reservoir receptacle 32 is shownin FIG. 77. The cap in FIG. 76 may be any of the caps described herein(e.g., cap 4, 204, 404, 504, 704, 804, 904 a-e, 964, 974, 984, 994, or1004) or other suitable cap.

In FIG. 77, the surface 4 a is an end surface of the cap (adjacent thecap open end that receives the reservoir). In other embodiments, thesurface 4 a may be any other predefined surface of the cap, or anextension or other structural feature of the cap. The bias member 1010in FIG. 77 is supported by a stop surface 32 a of the reservoirreceptacle 32, as described above. However, in the example embodiment ofFIG. 77, the stop surface 32 a is an annular protrusion on the innersurface 32 b of the reservoir receptacle 32.

In the embodiments of FIGS. 76 and 77 the bias member 1010 includes acoil spring. Other embodiments employ other types of bias members, suchas, but not limited to other forms of springs, magnetic orelectromagnetic bias members, compressed fluid bias members, or anycombination thereof, with or without a coil spring.

o. Other Connection Configurations

In other embodiments, the second releasable coupler includes one or moreother features, that engage and mate with one or more other features onthe housing of the infusion pump device 30, in the region of the openport of the reservoir receptacle 32. In particular embodiments, theinfusion pump device 30 is provided with an electronic solenoid devicethat selectively moves a solenoid plunger from a first position to asecond position, when energized (or when de-energized). In suchembodiments, the second releasable coupler includes one or more grooves,indentations, apertures, projections or other stop surfaces on the cap(e.g., cap 4, 404, 504, 704, 804 or on any other suitable capconfigurations) that are arranged to engage with the solenoid plunger,when the solenoid plunger is in the second position (i.e., when thesolenoid is energized, or de-energized, to move the plunger to thesecond position). When engaged with the stop surface on the cap, thesolenoid plunger locks and retains the cap within the reservoir, Whenthe solenoid plunger is in the second position, the plunger is withdrawnfrom the stop surface on the cap by an amount sufficient to unlock thecap from the reservoir receptacle and allow the cap to be removed fromthe reservoir receptacle (e.g., by manually pulling the cap in thedirection of axis A, out of the reservoir receptacle 32).

p. Side-Loading Reservoir Receptacle

In various embodiments described above, the reservoir receptacle 32 ofthe infusion pump device 30 has an end opening (an open end) throughwhich the axis A extends, for receiving a cap (or base/reservoir/capunit) inserted into the open end of the reservoir receptacle, along thedirection of the axis A. In further embodiments, the housing 33 of theinfusion pump device 30 has a side opening into the reservoir receptacle32 for receiving, from the side, a cap (or base/reservoir/cap unit),such as any of the caps (or base/reservoir/cap units) described herein,or other suitable cap (or base/reservoir/cap unit). In such embodiments,the cap 4 (or base/reservoir/cap unit) is inserted in a directiontransverse (for example, generally perpendicular) to the axis A, throughan open side of the reservoir receptacle 32.

For example, in the embodiment of FIGS. 78 and 79, the housing 33 of theinfusion pump device 30 includes a side opening 1013 (facing out of viewin the drawings)) having a size and a shape to receive a cap 1014 (orbase/reservoir/cap unit), laterally, through the side opening. Inparticular embodiments, a door or closure structure is provided to closethe side opening 1013 of the housing 33, once the cap 1014 (orbase/reservoir/cap unit) has been received within the reservoirreceptacle.

The cap 1014 has a raised port end 1016 (for example, corresponding theport 6 end of the cap 4 in FIGS. 1 and 2). In particular embodiments,the cap 1014 may be any of the caps described herein (e.g., cap 4, 204,404, 504, 704, 804, 904 a-e, 964, 974, 984, 994, or 1004) or othersuitable cap.

In the embodiment of FIGS. 78 and 79, the housing 33 of the infusionpump device covers both ends of the reservoir receptacle 32, in theaxial direction A. In that regard, a portion 1018 of the housing 33extends over (closes) the upper end of the reservoir receptacle 32. Thereservoir receptacle 32 is also closed on its bottom end (not shown inFIGS. 78 and 79). However, the portion 1018 over the upper end of thereservoir receptacle 32 includes a slot-shaped opening 1020 that is openon one end to the side opening 1013 of the reservoir receptacle, andextends across the top of the reservoir receptacle 32.

In the illustrated embodiment, the slot-shaped opening 1020 extendsacross at least a portion of the diameter of the reservoir receptacle32, and traverses the axis A of the reservoir receptacle 32. Theslot-shaped opening 1020 has a width dimension that is smaller than itslength dimension, so as to form an elongated, rectangular openingthrough the portion 1018 of the housing 33, into the reservoirreceptacle 32. The slot-shaped opening 1020 is configured to receive theraised port end 1016 of the cap 1014, when the cap 1014 (orbase/reservoir/cap unit) is received, through the side opening 1013,into the reservoir receptacle. As shown in FIG. 79, when the cap 1014(or base/reservoir/cap unit) is received within the reservoir receptacle32, the raised port end 1016 of the cap 1014 extends outward from thereservoir receptacle, through the slot-shaped opening 1020. In thatarrangement, the port on the raised port end 1016 is readily accessibleand unobstructed by the housing 33 of the infusion pump device 30,allowing for a greater flexibility in orientating the infusion settubing for user comfort, or allowing for ready access for connection ordisconnection of tubing from the raised port end 1016.

In embodiments as shown in FIGS. 78 and 79, the width dimension of theslot-shaped opening 1020 has a size that is able to receive the raisedport end 1016, when the raised port end 1016 (and, thus, the cap 1014and base/reservoir/cap unit) are aligned in a predefined rotationalorientation relative to the axis A. However, the width dimension of theslot-shaped opening 1020 is smaller than the diameter of the cap 1014,thus inhibiting the cap 1014 from passing through the slot-shapedopening 1020, when the cap 1014 (or base/reservoir/cap unit) is locatedwithin the reservoir receptacle 32.

In such embodiments, a first face or dimension of the raised port end1016 of the cap 1014 is wider than the width of the slot-shaped opening1020, while the width of a second face or dimension of the raised portend 1016 is smaller than the width of the slot-shaped opening 1020.Accordingly, in such embodiments, the slot-shaped opening 1020 can helpcontrol the rotational or angular orientation of the cap 1014 (orbase/reservoir/cap unit) relative to the axis A, when the cap 1014 (orbase/reservoir/cap unit) is received within the reservoir receptacle 32.In addition, the portion 1018 of the housing 33 can help retain the cap1014 (and base/reservoir/cap unit) from movement in the axial directionA relative to the housing 33 of the infusion pump device, when the cap1014 (or base/reservoir/cap unit) is received within the reservoirreceptacle 32.

In other embodiments as shown in FIGS. 80 and 81, the portion 1018 ofthe housing 33 is provided with a wider slot-shaped opening 1020′,having sufficient width to allow the raised port end 1016 of the cap1014 to fit through the open end of the slot-shaped opening 1020′ whileoriented with its wider face or dimension directed (facing) into theopen end of the slot-shaped opening 1020′ (i.e., facing toward the axisA). However, one or more dimensions of the slot-shaped opening 1020′ issmaller than the diameter of the cap 1014, thus inhibiting the cap 1014from passing through the slot-shaped opening 1020′, when the cap 1014(or base/reservoir/cap unit) is located within the reservoir receptacle32. The slot-shaped opening 1020′ includes an end surface 1022, againstwhich the wider side or face of the raised port end 1016 of the cap 1014abuts, when the cap 1014 (or base/reservoir/cap unit) is inserted intothe reservoir receptacle 32 through the side opening of the reservoirreceptacle 32. In particular embodiments, the end surface 1022 islocated and oriented such that, when the raised port end 1016 of the cap1014 is abutted against the end surface 1022, the cap 1014 (orbase/reservoir/cap unit) is arranged in a properly installed positionand orientation within the reservoir receptacle 32.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

5. Vents on Caps or Infusion Pump Device

In further examples of any of the embodiments described herein, the cap(e.g., cap 4, 404, 504, 704, 804, 904 a-e, 964, 974, 984, 994, 1004,1014, or other suitable cap) is provided with one or more vent openings(such as vent openings 24 described above with respect to cap 4). Thevent opening(s) 24 provide one or more air passages from the environmentoutside of the cap, to the interior volume of the cap body. Accordingly,when the cap (or base/reservoir/cap unit) is installed in a reservoirreceptacle 32, the vent opening(s) provide an air flow passage orpressure equalization passage between the environment outside of the capand infusion pump device, to the environment within the reservoirreceptacle 32 (i.e., the volume between the base/reservoir/cap unit andthe interior wall of the reservoir receptacle 32, when thebase/reservoir/cap unit is received within the reservoir receptacle 32).

In particular embodiments, the vent opening(s) 24 include a hydrophobicmaterial that inhibits the passage of water or other liquid through thevent opening(s). For example, the hydrophobic material may be providedas a membrane over one or both open ends (interior and exterior ends) ofeach vent opening, or within vent opening. In other embodiments, anabsorbent material is provided in or adjacent each vent opening toabsorb or wick away liquid that may drop or accumulate on the surface ofthe cap or the port of the reservoir receptacle 32.

In those or other embodiments, a wiper structure that wipes any residualliquid off of the surface of the reservoir when the reservoir isdisengaged from a transfer guard (e.g., transfer guard 200 or 300described herein), or engaged with a cap (e.g., any of the capsdescribed herein).

An example embodiment of a vent configuration in a cap 1024 is describedwith reference to FIG. 82. In particular embodiments, the cap 1024 maybe any of the caps described herein (e.g., cap 4, 204, 404, 504, 704,804, 904 a-e, 964, 974, 984, 994, 1004 or 1014) or other suitable cap.

A cut-away view of a cap 1024 is shown in FIG. 82, where the cap 1024includes a plurality of vent openings 1028 (two of which are shown inview in FIG. 82). The vent openings 1028 are provided in a top wall ofthe cap 1024 and are arranged around the infusion set tubing port 1026of the cap 1024. In the embodiment of FIG. 82, the inside surface of thecap 1024 (the surface facing the reservoir 1, when the cap 1024 isarranged on the reservoir 1) is provided with an annular groove 1030that surrounds the inner opening 1032 to the port 1026. The ventopenings 1028 are arranged within the annular groove 1030.

In addition, a first annular array of weld horns 1034 (or otherattachment mechanisms) is provided around and concentric with theannular groove 1030. In particular embodiments, a second annular arrayof weld horns 1036 (or other attachment mechanisms) is provided betweenthe annular groove 1030 and the inner port opening 1032, and concentricwith the annular groove 1030 (and, thus, concentric with the firstannular array 1036). In further embodiments, the second annular array ofweld horns 1036 (or other attachment mechanisms) may be omitted.

The first and second annular arrays 1034 and 1036 secure a membrane 1038to the inner surface of the cap 1024, over the annular groove 1030 andvent openings 1028. In particular, the first and second annular arrays1034 and 1036 fix the membrane 1038 to the inner surface of the cap 1024in two concentric, annular attachment zones on either side of theannular groove 1030. In particular embodiments, the membrane 1038 ismade of (or coated with) a hydrophobic material that repels water, butallows the passage of air.

When affixed to the inner surface of the cap 1024, the membrane 1038covers the groove 1030, but is separated from the vent openings 1028 bythe depth of the annular groove 1030. Accordingly, the annular groove1030 provides an unobstructed, annular air flow path between themembrane 1038 and the inner surface of the cap 1024. The vent openings1028 are arranged around and in air flow communication with the annularair flow path in the annular groove 1030.

The membrane 1038 includes a central opening 1038 a that aligns with theinner port opening 1032 when the membrane 1038 is attached to the innersurface of the cap 1024. In other embodiments, the central portion ofthe membrane 1038 does not include a central opening 1038 a, but,instead, is configured to be pierced by a needle of the infusion set 50,when the infusion set tubing 52 is attached to the port 1026.

In particular embodiments, the first and second arrays of weld horns (orother attachment mechanisms) comprises arrays of ultrasonic weld horns.In such embodiments, the membrane is secured to the inner surface of thecap 1024 by pressing the membrane 1038 against the arrays of weld hornsand applying ultrasonic energy to the weld horns sufficient to weld themembrane to the cap 1024. In other embodiments, other suitableattachment mechanisms may be employed including, but not limited to aglue or other adhesive material.

When secured to the inner surface of the cap 1024, the membrane 1038allows the passage of air, but inhibits the passage of moisture throughthe vents 1028. The annular groove 1030 enhances the air flow throughthe vent openings 1028 and membrane 1038, by increasing the surface areaof the membrane 1038 exposed to the air flow path (relative to amembrane arranged directly over the vent openings 1028).

While embodiments described above include vent openings and membraneslocated on caps (e.g., cap 1024), other embodiments described withreference to FIG. 83 include one or more vent openings (with or withoutmembranes) on an upper ring member 1040 connected to (or connectable to)the housing 33 of the infusion pump device 30, over the open end of thereservoir receptacle 32. The upper ring member 1040 may be any of theupper ring members described herein (including, but not limited to upperring member 94, 137, 910, 932, 990), or other suitable upper ringmember.

In the embodiment of FIG. 83, the upper ring member 1040 includes acentral opening 1040 a and one or more (or a plurality of) vent openings1042 extending through the ring member 1040 to the interior of thereservoir receptacle 32. The upper ring member 1040 may also include oneor more key tabs or protrusions 1041 that engage or fit within one ormore corresponding key slots or recesses in the housing 33 of theinfusion pump device 30, to inhibit rotation of the upper ring member1040 relative to the housing 33 (or to properly position the upper ringmember 1040 relative to the housing 33). In other embodiments, thepositions of the key tab(s) or protrusion(s) and key slot(s) orrecess(es) are reversed, such that the key tab(s) or protrusion(s) areon the housing 33 and the key slot(s) or recess(es) are on the upperring member 1040.

In the drawing of FIG. 83, two vent openings 1042 are provided in theupper ring member 1040, through a side wall of the upper ring member onopposite sides of the axis A. In other embodiments, the upper ringmember 1040 includes only one vent opening 1042. In other embodiments,the upper ring member 1040 includes more than two vent openings arrangedaround the circumference of the upper ring member (around the axis A).In yet further embodiments, one or more vent openings are providedthrough the free end surface (upward-facing surface in FIG. 83) of theupper ring member 1040.

In particular embodiments, each vent opening 1042 is covered with amembrane 1038, as described above. The membrane 1038 may be provided onthe interior surface of the upper ring member 1040 (the surface facinginto the central opening 1040 a), and covering over the vent opening1042. In other embodiments, the membrane 1038 is provided on theexterior surface of the upper ring member 1040 (the surface facingoutward relative to the axis A), and covering over the outside of thevent opening 1042. In yet other embodiments, the membrane 1038 isprovided inside of the vent opening 1038 flush with or recessed from oneor both of the interior surface and exterior surface of the upper ringmember 1040.

In various embodiments described above, the cap 4 (or cap 204, 404, 504,704, 804, 904 a-4, 1050, 974, 984, 994, 1004, 1014, 1024, or other capas described herein) includes or operates with a hollow needle (such asneedle 9) that pierces a septum in the reservoir 1, to provide a fluidflow path between the interior of the reservoir 1 and the tubing 52.Other embodiments employ a needle-free connection between the cap andthe reservoir, an example of which is shown in FIGS. 84-86. In theembodiment of FIGS. 84-86, a cap 1050 is provided with a hollow, centralchannel or passage 1052 extending from a first open end 1052 a at a port1054 to a second open end 1052 b. As described herein, the channel orpassage 1052 provides a needle-free, fluid flow path from the port 1054,into the interior of a reservoir 1.

The cap 1050 includes a cap body having a rounded end portion 1050 a.The rounded end portion 1050 a of the cap body has an outer surface thathas a semi-spherical or semi-spheroidal shape, with the second open end1052 b of the passage 1052 located at the apex of the semi-spherical orsemi-spheroidal shape. The cap body has a port portion 1050 b (the upperportion of the cap 1050 in FIGS. 84 and 85, on which the port 1054 islocated. The port 1054 may be similar to the port 6 described above andmay connect with a tubing 52 of an infusion set 50, as described abovewith respect to port 6. A ridge portion 1050 c of the cap body extendsaround the cap body, between the rounded end portion 1050 a and the portportion 1050 b of the cap 1050. In particular embodiments, the cap body(including the rounded end portion 1050 a, the port portion 1050 b andthe ridge portion 1050 c) is formed as a single, unitary structure by,for example, but not limited to a single molded or machined structure,or the like. In other embodiments, the cap body (including the roundedend portion 1050 a, the port portion 1050 b or the ridge portion 1050 c)are made of separate elements that are connected together to form thebody of the cap 1050.

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

6. Pivotal Cap-to-Reservoir Connection

In the embodiment of FIGS. 84-86, the cap 1050 is configured to beselectively placed onto an open end of the body of a reservoir 1, withthe rounded end portion 1050 a of the cap body extending at leastpartially into the open end of the reservoir 1. When the cap 1050 isplaced onto the open end of the reservoir 1, the rounded end portion1050 a of the cap 1050 is arranged to contact and seal against anannular seal structure 1054 located within the reservoir 1. The rounded(semi-spherical or semi-spheroidal) shape of the rounded end portion1050 a allows the surface of the rounded end portion 1050 a to sealagainst the annular seal structure 1054, around the entire periphery ofthe cap 1050.

In particular embodiments, the annular seal structure 1054 includes anO-ring, band, or other suitable seal, made of silicon rubber or othersuitable, flexible sealing material. The annular seal structure 1054 isarranged around the inner periphery of an inner surface of the reservoir1, either at or a selected distance below the open end of the reservoir1 (for example, in a head or neck portion of the reservoir 1, where thehead or neck portion of the reservoir 1 has a smaller diameter than therest of the body of the reservoir 1). In particular embodiments, theinner surface of the reservoir 1 (or of the head or neck portion of thereservoir 1) is provided with an annular groove 1056 a, rib or ridge1056 b, or both (or other retaining surface) that abuts the annular sealstructure 1054 and helps retain the annular seal structure 1054 in afixed location within the reservoir 1.

In the embodiment of FIGS. 84-86, the cap 1050 is connected to thehousing of the reservoir 1 (e.g., at the head or neck portion of thereservoir 1, or other location adjacent the open end of the reservoir 1)by a hinged or pivotal connection structure 1058. In the illustratedembodiment, the pivotal connection structure 1058 includes a first hingeportion 1058 a on the cap 1050, a second hinge portion 1058 b on thereservoir 1, and a pivot pin 1058 c defining a pivot axis P_(A) alongits length. The first hinge portion 1058 a connects with the secondhinge portion 1058 b, through the pivot pin 1058 c, for pivotal rotationrelative to each other (e.g., by extending the pivot pin 1058 c throughaligned openings in the first and second hinge portions 1058 a and 1058b and fixing the pivot pin 1058 c within those openings to allow one orboth of the hinge portions 1058 a and 1058 b to rotate about the pivotaxis P_(A) of the pivot pin 1058 c).

In this manner, the cap 1050 is pivotal between an open position inwhich the rounded end portion 1050 a is located outside of the reservoir1, and a closed position in which the rounded end portion 1050 a islocated at least partially within the reservoir 1 and abutted againstthe seal structure 1054. When in the closed position, the cap 1050provides a fluid-tight seal with the seal structure 1054 in thereservoir 1, to seal the cap 1050 to the reservoir 1. In particularembodiments, one or more latches, clips or other securing mechanisms areprovided on the cap 1050, the reservoir 1, or both, to selectivelysecure the cap 1050 in the closed position, to inhibit accidental orunauthorized opening of the cap 1050 from the closed position on thereservoir 1. In other embodiments, the rounded end portion 1050 a andthe seal structure 1054 provide a friction fit sufficient to retain thecap 1050 in a closed position.

In particular embodiments, the ridge portion 1050 c of the body of thecap 1050 is configured to be located outside of the reservoir 1 (and, insome embodiments, to abut an upper edge of the reservoir 1 around theopen end of the reservoir 1) when the cap 1050 is in a closed positionrelative to the reservoir 1. In such embodiments, the ridge portion 1050c has an outer peripheral edge with a diameter that is greater than theouter diameter of the opening in the open end of the reservoir 1, sothat the ridge portion 1050 c overlaps the upper edge of the reservoir1, when the cap 1050 is in a closed position. In further embodiments,one or more seals may be arranged on one or both of the ridge portion1050 c and the upper edge of the reservoir 1, to provide a fluid sealbetween the ridge portion 1050 c and the upper edge of the reservoir 1,when the cap 1050 is in a closed position.

In the embodiment of FIGS. 84 and 85, the first hinge portion 1058 a isfixed to the ridge portion 1050 c of the body of the cap 1050, so as tobe located at a maximum distance, radially, from a center line of thecap 1050 (extending through the passage 1052). The second hinge portion1058 b is fixed to the body of the reservoir 1, for example at or nearthe upper edge of the reservoir 1. Thus, when the first and second hingeportions 1058 a and 1058 b are pivotally connected together by the hingepin 1058 c, the cap 1050 is able to be selectively pivoted in onedirection a sufficient distance to an open position at which the roundedend portion 1050 a of the body of the cap 1050 is fully outside of thereservoir 1. In addition, from the open position, the cap 1050 is ableto be selectively pivoted in a second direction (opposite to the onedirection) to a closed position at which the rounded end portion 1050 aof the body of the cap 1050 is abutted against (and sealed against) theseal structure 1054. In the closed position, the cap 1050 is sealed withthe reservoir 1, but provides a needle-free fluid flow path through thepassage 1052, for example, to an infusion set tubing (such as tubing52).

Moreover, in the representative drawing figures of embodiments of thepresent invention throughout this specification, the cap 4 may beillustrated without a reservoir 1 for sake of simplicity; however, it isknown to those skilled in the art that the cap 4 may be coupled with thereservoir 1 according to embodiments of the present invention.

7. Transfer Guard with Cap Lock

In various embodiments described herein, a reservoir 1 may be filled(partially or completely) with an infusion media prior to being coupledwith a cap (or in a base/reservoir/cap unit). The infusion media may beany suitable fluid capable of being dispensed from an infusion pumpdevice (such as, but not limited to infusion pump device 30) or otherdelivery device. In particular embodiments, the infusion media includesinsulin or an insulin formulation for treatment of diabetes. In otherembodiments, the infusion media includes other suitable substances orformulations for medicinal, therapeutic, or other purposes including,but not limited to a formulation for treatment of cancer, humanimmunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS),or other disease or condition.

In particular embodiments, a transfer guard device is employed toconnect a vial or other container of infusion media to the reservoir, totransfer fluidic media from the vial or other container to thereservoir. An example embodiment of a transfer guard device 1060 isdescribed with reference to FIGS. 87 and 88.

The transfer guard device 1060 is configured to selectively connect avial 1062 or other container of fluidic media to a reservoir 1, totransfer fluidic media from the vial 1062 to the reservoir 1 (to fillthe reservoir 1 partially or completely with the fluidic media). Thevial 1062 or other container may contain any suitable fluidic media,including, but not limited to the examples of infusion media describedherein.

The transfer guard device 1060 is configured to be connected to areservoir 1 and to a vial 1062 or other container for and during afilling operation. In particular embodiments, the transfer guard device1060 is configured to inhibit disconnection (accidental or unauthorizeddisconnection) of the transfer guard device 1060 from the reservoir,prior to completion of a filling operation. As such, accidental orunauthorized spilling of fluidic media from the vial 1062 or othercontainer onto the top of the reservoir 1 (or elsewhere) can be avoidedor minimized. The transfer guard device 1060 is configured to disconnectfrom the reservoir 1 (or from the reservoir 1 and the vial 1062), aftercompletion of a fill operation, to allow the reservoir 1 to be coupledwith a cap (for example, in a base/reservoir/cap unit) as describedherein.

With reference to FIGS. 87 and 88, the transfer guard device 1060includes a first end having a cup-shaped cap or enclosure 1064configured to receive and at least partially enclose a port end of thereservoir 1. The transfer guard device 1060 includes a second end havinga second cup-shaped cap or enclosure 1066 configured to receive and atleast partially enclose a port end of the vial 1062 or other containerof fluidic media.

The transfer guard 1060 also includes a fluid channel formed of one ormore hollow needle or tube structures 1068 arranged to connect in fluidcommunication with the reservoir 1 and the vial 1062 or other container,when the port end of the reservoir 1 and the port end of the vial 1062or other container are received in the first and second enclosures 1064and 1066, respectively. In particular embodiments, the fluid channelincludes a hollow needle structure having a first sharp end 1068 aarranged to pierce a septum in the reservoir 1 and be in fluid flowcommunication with the interior of the reservoir 1, when the port end ofthe reservoir 1 is fully received within the first enclosure 1064.

The first enclosure 1064 fits over a base 1070 attached to the reservoir1 (where the base 1070 may be similar to base 2 described herein, butwith apertures as described below). In particular embodiments, the base1070 is mounted to the port end of the reservoir 1 in a non-rotationalmanner (such that the base 1070 is not allowed to rotate relative to thereservoir 1). Also in particular embodiments, the first enclosure 1064attaches to the port end of the reservoir 1, by a rotational motion(e.g., rotating in one direction, such as, but not limited to aclockwise direction) around the axis AAA. Similarly, the first enclosure1064 detaches from the port end of the reservoir 1, by a rotationalmotion (e.g., rotating in a second direction, such as, but not limitedto a counterclockwise direction) around the axis AAA. In suchembodiments, the first enclosure 1064 and the port end of the reservoir1 (or the base 1070 on the port end of the reservoir 1) is provided witha rotatable connection structure, such as, but not limited to screwthreads, a slot and tab structure or other suitable structure thatallows the first enclosure 1064 and the port end of the reservoir 1 toselectively connect and disconnect by relative rotary motion betweenthose parts (i.e., rotary motion about the axis AAA).

The one or more hollow needle or tube structures 1068 of the fluidchannel includes a second sharp end 1068 b arranged to pierce a septumin the vial 1062 or other container, and be in fluid flow communicationwith the interior of the vial 1062 or other container when the port endof the vial 1062 or other container is fully received within the secondenclosure 1066. In particular embodiments, the second enclosure 1066fits over the port end of the vial 1062 or other container and isconfigured to connect to the port end of the vial 1062 or othercontainer by snap or friction fit.

The transfer guard device 1060 includes a section 1071 connecting thefirst and second enclosures 1064 and 1066 together. The one or morehollow needle or tube structures 1068 of the fluid channel extendsthrough the section 1071. In addition, one or more (or a plurality) ofmovable members 1072 are arranged on or along the length of the section1071. In particular embodiments, each moveable member 1072 includes apin, post or plate of suitably rigid material that is supported by thefirst and second enclosures 1064 and 1066 for selective movement in thelongitudinal direction of the axis AAA.

In the embodiment in FIGS. 87 and 88, each moveable member 1072 has afirst end 1072 a extending through an opening 1064 a in the firstenclosure 1064. In addition, each moveable member 1072 has a second end1072 b extending through an opening 1066 a in the second enclosure 1066.The second end 1072 b of each moveable member 1072 is arranged to beengaged and abutted by the port end of the vial 1062 or other container,when the port end of the vial 1062 or other container is received withinthe second enclosure 1066. In particular, as the port end of the vial1062 or other container is being received within the second enclosure1066, the port end of the vial 1062 or other container abuts and pushesagainst the second end 1072 b of each movable member 1072 and causeseach moveable member 1072 to move in the axial direction AAA from afirst position to a second position (downward in the orientation ofFIGS. 87 and 88).

More specifically, prior to the port end of the vial 1062 or othercontainer being received within the second enclosure 1066 (as shown inFIG. 87), each moveable member 1072 is in a first position shown in FIG.87. However, when the port end of the vial 1062 or other container isfully received within the second enclosure 1066 (as shown in FIG. 88),each moveable member 1072 is in a second position shown in FIG. 88. Inthe first position (FIG. 87) of the moveable member(s) 1072, the firstend 1072 a of each moveable member 1072 is separated from and outside ofan opening 1070 a in the base 1070. However, in the second position(FIG. 88) of the moveable member(s) 1072, the first end 1072 a of eachmoveable member 1072 extends at least partially into a respectiveopening 1070 a in the base 1070.

Accordingly, when each moveable member 1072 is in a first position shownin FIG. 87, the transfer guard 1060 is allowed to be rotated about theaxis AAA relative to the reservoir 1 (and base 1070 attached to thereservoir 1). Thus, in the first position of the moveable member(s)1072, the transfer guard 1060 can be rotated relative to the reservoir1, to allow rotational connection (or disconnection) of the enclosure1064 of the transfer guard 1060 from the port end of the reservoir 1. Inthat regard, prior to the port end of the vial 1062 or other containerbeing received within the second enclosure 1066, or after removal of theport end of the vial 1062 or other container from the second enclosure1066 (as shown in FIG. 87), the transfer guard 1060 is able to beselectively rotated relative to the reservoir 1, to allow selectiveconnection or disconnection of the enclosure 1064 to or from the portend of the reservoir 1.

However, when the moveable members 1072 are in the second position shownin FIG. 88, moveable members 1072 extend at least partially intoopenings 1070 a in the base 1070 and inhibit rotation of the transferguard 1060 about the axis AAA relative to the base 1070 and reservoir 1.Thus, in the second position of the moveable member(s) 1072, thetransfer guard 1060 is inhibited from being rotated relative to thereservoir 1, thus inhibiting disconnection of the enclosure 1064 of thetransfer guard 1060 from the port end of the reservoir 1. In thatregard, when the port end of the vial 1062 or other container is fullyreceived within the second enclosure 1066 (as shown in FIG. 88), thetransfer guard 1060 is inhibited from being rotated relative to thereservoir 1 and, thus, the enclosure 1064 is inhibited from beingdisconnected from the port end of the reservoir 1.

Therefore, accidental or unauthorized removal of the transfer guard 1060from the reservoir 1 is inhibited, as long as the port end of the vial1062 or other container is fully received within the enclosure 1066. Thetransfer guard 1060, thus, can provide additional safety and preventundesired disconnection of the reservoir 1, while the vial 1062 or othercontainer is connected in flow communication with the fluid channel 1068in the transfer guard 1060.

The transfer guard device 1060 and components thereof may be made of anysuitably rigid material having sufficient rigidity and strength tooperate as described herein, including, but not limited to plastic,metal, ceramic, wood, composite material, or the like, or anycombination thereof. While various embodiments described herein mayemploy a transfer guard 1060 to fill a reservoir prior to installationof the reservoir in an infusion pump device 30, other embodiments employother suitable mechanisms and procedures for filling reservoirs, oremploy pre-filled reservoirs.

While the description above refers to particular embodiments of thepresent invention, it will be understood that many modifications may bemade without departing from the spirit thereof. The accompanying claimsare intended to cover such modifications as would fall within the truescope and spirit of the present invention. The presently disclosedembodiments are therefore to be considered in all respects asillustrative and not restrictive, the scope of the invention beingindicated by the appended claims rather than the foregoing description,and all changes which come within the meaning and range of equivalencyof the claims are therefore intended to be embraced therein.

What is claimed is:
 1. A connector interface system, comprising: a capto connect to a reservoir to form a reservoir/cap unit for installationinto an infusion pump device; and at least two detectable featuresarranged on the cap for detection by at least one sensor element on theinfusion pump device when the reservoir of the reservoir/cap unit isreceived in a reservoir receptacle of the infusion pump device, whereinthe at least two detectable features include at least one detectableparameter that is associated with one or more characteristics of thecap, the reservoir, a cannula, or a tubing connected between the cap andthe cannula; wherein the one or more characteristics of the cap, thereservoir, the cannula, or the tubing includes a type or identity of amanufacturer of the cap, the reservoir, the cannula or the tubing, or asize of the cap, the reservoir, the cannula or the tubing; and whereinthe at least two detectable features are detected by the at least onesensor element when the cap is in a proper or fully installed positionwithin the reservoir receptacle of the infusion pump device.
 2. Aconnector interface system as recited in claim 1, wherein a first of theat least two detectable features includes a magnet that is attached to ahousing of the cap, and a second of the at least two detectable featuresinclude a radio frequency identification (RFID) chip that is attached tothe housing of the cap.
 3. A connector interface system as recited inclaim 2, wherein the first of the at least two detectable features is amagnetic field angle of the magnet, wherein the magnetic field anglebeing an angle of orientation of the magnetic field of the magnetrelative to a predefined axis of the cap or the reservoir/cap unit.
 4. Aconnector interface system as recited in claim 2, wherein the RFID chipcontains data representing one or more of the following characteristics:the type or identity of the manufacturer of the reservoir, cap orinfusion pump device; the size of the reservoir, cap or infusion pumpdevice; a type or concentration of infusion media in the reservoir; avolume amount of infusion media in the reservoir; a date correspondingto a manufacturing date, expiration date or fill date related toinfusion media in the reservoir; a date corresponding to a manufacturingdate or expiration date of the reservoir, cap or infusion pump device; alocation corresponding to a place where the reservoir or infusion mediain the reservoir was made, filled, or otherwise processed; a locationcorresponding to a place where the cap or infusion pump device was made,assembled or otherwise processed; a location corresponding to a placewhere the reservoir, infusion media in the reservoir, cap or infusionpump device is authorized to be used; a lot number or code associatedwith a batch in which the reservoir, cap, infusion pump device orinfusion media was made, cleaned, filled or otherwise processed; aserial number; a unique ID; and user identification information forauthorized users.
 5. A connector interface system as recited in claim 2,wherein a first of the at least one sensor element detects the magnet,and a second of the at least one sensor element is a RFID chip reader toread data from the RFID chip.
 6. A connector interface system as recitedin claim 1, wherein a first of the at least two detectable featuresincludes a magnet that is attached to a housing of the cap, and a secondof the at least two detectable features includes an inductivelydetectable feature attached to the housing of the cap.
 7. A connectorinterface system as recited in claim 6, wherein the first of the atleast two detectable features is a magnetic field angle of the magnet,wherein the magnetic field angle being an angle of orientation of themagnetic field of the magnet relative to a predefined axis of the cap orthe reservoir/cap unit.
 8. A connector interface system as recited inclaim 6, wherein the inductively detectable feature comprises: (a) oneor more electrically conductive targets in one or more locations forinductive interaction with one or more coils when the reservoir/cap unitis received in the reservoir receptacle; or (b) a plurality ofelectrically conductive targets in locations that allow the one or moreelectrically conductive targets to inductively interact with the one ormore coils to provide detectable signals for detection of axial orrotational motion or position of the cap or the reservoir relative tothe reservoir receptacle, when the reservoir/cap unit is received in thereservoir receptacle.
 9. A connector interface system as recited inclaim 6, wherein a first of the at least one sensor element detects themagnet, and a second of the at least one sensor element is an inductivesensor to detect the inductively detectable feature.
 10. A connectorinterface system as recited in claim 1, wherein a first of the at leasttwo detectable features includes a magnet that is attached to a housingof the cap, and a second of the at least two detectable featuresincludes a RF detectable feature attached to the housing of the cap. 11.A connector interface system as recited in claim 10, wherein the firstof the at least two detectable features is a magnetic field angle of themagnet, wherein the magnetic field angle being an angle of orientationof the magnetic field of the magnet relative to a predefined axis of thecap or the reservoir/cap unit.
 12. A connector interface system asrecited in claim 10, wherein: (a) the RF detectable feature comprises aradio frequency identification (RFID) tag that is attached to thehousing of the cap, to the reservoir, or on a plunger within thereservoir; (b) the RF detectable feature comprises a passive RF devicethat receives power through inductive coupling with a RF sensor; (c) theRF detectable feature comprises an RF detectable device having adirectional antenna or an antenna with at least one RF shield or waveguide configured to direct RF signals to or from the antenna; (d) the RFdetectable feature comprises an RF detectable device having an antenna,the antenna being arranged adjacent or in a vent opening on the cap; (e)the RF detectable feature comprising an antenna printed with conductiveink on the cap, the reservoir, or a label applied to the reservoir orcap; or (f) the RF detectable feature has a memory that storesinformation, and an antenna for communicating information stored in thememory, the memory includes a first section that stores permanentinformation and a second section that is writeable for storinginformation written to the RF detectable feature, where: (i) theinformation stored in the memory comprises information identifying oneor more of: the type or identity of the manufacturer of the reservoir;the size of the reservoir; a type or concentration of infusion media inthe reservoir; a volume amount of infusion media in the reservoir; avolume amount of infusion media that has been dispensed from thereservoir; a date corresponding to an expiration date or fill daterelated to infusion media in the reservoir; a location corresponding toa place where the reservoir or infusion media in the reservoir was made,filled, or otherwise processed; a lot number or code associated with abatch in which the reservoir or infusion media was made, cleaned, filledor otherwise processed; (ii) the information stored in the memorycomprises information identifying one or more characteristics relatingto an infusion set connected to the cap, the one or more characteristicsincluding at least one of: a type or identity of a manufacturer of theinfusion set; a length of tubing in the infusion set; a diameter of thetubing in the infusion set; a length of a needle or cannula in theinfusion set; a diameter of the needle or cannula in the infusion set; adate corresponding to an expiration date, manufacturing date or assemblydate of the infusion set; a location corresponding to a place where theinfusion set was made or assembled; a lot number or other codeassociated with a batch in which the infusion set was made, cleaned orotherwise processed; or (iii) the information stored in the memorycomprises information identifying one or more characteristics of theconnector interface system, the one or more characteristics including atleast one of a type or manufacturer of the connector interface system; asize dimension of the cap; a date corresponding to an expiration date,manufacturing date or assembly date of the connector interface system; alocation corresponding to a place where the connector interface systemwas made or assembled; a lot number or other code associated with abatch in which the connector interface system was made, cleaned orotherwise processed.
 13. A connector interface system as recited inclaim 10, wherein a first of the at least one sensor element detects themagnet, and a second of the at least one sensor element is a RF sensorto detect the RF detectable feature.
 14. A connector interface system asrecited in claim 1, wherein a first of the at least two detectablefeatures includes a magnet that is attached to a housing of the cap, anda second of the at least two detectable features includes a mechanicallydetectable feature attached to the housing of the cap.
 15. A connectorinterface system as recited in claim 14, wherein the first of the atleast two detectable features is a magnetic field angle of the magnet,wherein the magnetic field angle being an angle of orientation of themagnetic field of the magnet relative to a predefined axis of the cap orthe reservoir/cap unit.
 16. A connector interface system as recited inclaim 14, wherein the mechanically detectable feature comprises at leastone protrusion on an outer surface of the cap or the reservoir, aplurality of protrusions at mutually different locations on the cap orthe reservoir, or first and second protrusions located about 180 degreesfrom each other with respect to a central axis through the cap or thereservoir.
 17. A connector interface system as recited in claim 14,wherein a first of the at least one sensor element detects the magnet,and a second of the at least one sensor element is a mechanicaldetection sensor element to detect the mechanically detectable feature.18. A connector interface system as recited in claim 1, wherein a firstof the at least two detectable features includes a magnet that isattached to a housing of the cap, and a second of the at least twodetectable features includes an optically detectable feature attached tothe housing of the cap.
 19. A connector interface system as recited inclaim 18, wherein the first of the at least two detectable features is amagnetic field angle of the magnet, wherein the magnetic field anglebeing an angle of orientation of the magnetic field of the magnetrelative to a predefined axis of the cap or the reservoir/cap unit. 20.A connector interface system as recited in claim 18, wherein theoptically detectable feature comprises: (a) at least one surface of thecap or the reservoir that has at least one of a material, coating,surface contour or pattern, ribs, grooves, undulations, roughness,abrasions, apertures, detents or an attached article, that inhibits orchanges optical reflective characteristics of the at least one surfaceof the cap; (b) a bar code, matrix code or other optically detectablepattern that represents encoded information; or (c) an adhesive-backedtag that adheres to the cap and that has an outer surface configured toalter an optical signal in an optically detectable manner.
 21. Aconnector interface system as recited in claim 18, wherein a first ofthe at least one sensor element detects the magnet, and a second of theat least one sensor element is an optical sensor to detect the opticallydetectable feature.
 22. A connector interface system as recited in claim1, wherein a first of the at least two detectable features includes amagnet that is attached to a housing of the cap, and a second of the atleast two detectable features includes an electrically detectablefeature attached to the housing of the cap.
 23. A connector interfacesystem as recited in claim 22, wherein the first of the at least twodetectable features is a magnetic field angle of the magnet, wherein themagnetic field angle being an angle of orientation of a magnetic fieldof the magnet relative to a predefined axis of the cap or thereservoir/cap unit.
 24. A connector interface system as recited in claim22, wherein the electrically detectable feature is an electrical contactconnected to a chip inside the cap having an internal memory containingdata about the cap or the reservoir, and the at least one sensor elementis configured to receive the data for communication to the infusion pumpdevice.
 25. A connector interface system as recited in claim 22, whereina first of the at least one sensor element detects the magnet, and asecond of the at least one sensor element is a sensor to detect theelectrically detectable feature.
 26. A connector interface system asrecited in claim 1, wherein a first of the at least one sensor elementdetects a first of the at least two detectable features, and a second ofthe at least one sensor element detects a second of the at least twodetectable features.